Recall archive / FDA device enforcement

Intraocular lens. enVista Monofocal IOL, All models starting with EE; enVista Aspire IOL, All models starting with EA... — FDA record Z-1679-2025

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Mar 27, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Intraocular lens. enVista Monofocal IOL, All models starting with EE; enVista Aspire IOL, All models starting with EA; enVista Monofocal Toric IOL, All models starting with ETE; enVista Aspire Toric IOL, All models starting with ETA;
Reason: In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy IOLs, and certain enVista monofocal lenses in the U.S.
Classification: Class I
Recalling firm: Bausch & Lomb Surgical, Inc.
Quantity: 236,840
Agency-reported status: Ongoing
Source record identifier: Z-1679-2025

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	Description/Lots/UDI-DI: enVista Monofocal IOL (EEU)/3Q25120, 3Q25326, 3Q25327, 3Q25347, 3Q25348, 3Q25425, 3Q25426, 3Q25427, 3Q25507, 3Q25508, 3Q25509, 3Q25510, 3Q25511, 3Q25548, 3Q25549, 3Q25550, 3Q25628, 3Q25632, 3Q25730, 3Q25731, 3Q25840, 3Q25843, 3Q25934, 3Q25935, 3Q25936, 3Q25937, 3Q25938, 3Q25939, 3Q25940, 3Q25941, 3Q25942, 3Q25943, 3Q25944, 3Q26009, 3Q26010, 3Q26041, 3Q26042, 3Q26043, 3Q26044, 3Q26069, 3Q26070, 3Q26071, 3Q26072, 3Q26119, 3Q26120, 3Q26121, 3Q26122, 3Q26123, 3Q26202, 3Q26203, 3Q26204, 3Q26220, 3Q26255, 3Q26262, 3Q26301, 3Q26305, 3Q26306, 3Q26328, 3Q26329, 3Q26330, 3Q26331, 3Q26332, 3Q26333, 3Q26334, 3Q26348, 3Q26422, 3Q26424, 3Q26425, 3Q26444, 3Q26445, 3Q26446, 3Q26520, 3Q26521, 3Q26522, 3Q26614, 3Q26617, 3Q26618, 3Q26681, 3Q26682, 3Q26683, 3Q26684, 3Q26733, 3Q26734, 3Q26735, 3Q26747, 3Q26801, 3Q26802, 3Q26833, 3Q26834, 3Q26835, 3Q26836, 3Q26911, 3Q26912, 3Q26913, 3Q26914, 3Q26916, 3Q27101, 3Q27102, 3Q27103, 3Q27104, 3Q27201, 3Q27202, 3Q27203, 3Q27226, 3Q27253, 3Q27254, 3Q27255, 3Q27336, 3Q27337, 3Q27450, 3Q27451, 3Q27452, 3Q27453, 3Q27454, 3Q27455, 3Q27520, 3Q27620, 3Q27808, 3Q27809, 3Q27928, 3Q27929, 3Q27930, 3Q28021, 3Q28022, 3Q28101, 3Q28137, 3Q28138, 3Q28139, 3Q28712, 3Q28713, 3Q28714, 3Q28812, 3Q28813, 3Q28815, 3Q28816, 3Q28913, 3Q28914, 3Q28915, 3Q29033, 3Q29034, 3Q29140, 3Q29141, 3Q29142, 3Q29215, 3Q29216, 3Q29217, 3Q29218, 3Q29255, 3Q29319, 3Q29320, 3Q29422, 3Q29423, 3Q29424, 3Q29425, 3Q29524, 3Q29526, 3Q29537, 3Q29646, 3Q29647, 3Q29648, 3Q29649, 3Q29723, 3Q29724, 3Q29725, 3Q29726, 3Q29727, 3Q29817, 3Q29818, 3Q29904, 3Q29905, 3Q29924, 3Q30032, 3Q30033, 3Q30034, 3Q30141, 3Q30142, 3Q30143, 3Q30144, 3Q30145, 3Q30215, 3Q30250, 3Q30253, 3Q30325, 3Q30326, 3Q30442, 3Q30443, 3Q30444, 3Q30525, 3Q30526, 3Q30527, 3Q30528, 3Q30529, 3Q30602, 3Q30638, 3Q30639, 3Q30640, 3Q30641, 3Q30644, 3Q30645, 3Q30833, 3Q30834, 3Q30835, 3Q30836, 3Q30928, 3Q30929, 3Q30930, 3Q30948, 3Q30949, 3Q31005, 3Q31044, 3Q31045, 3Q31136, 3Q31138, 3Q31140, 3Q31233, 3Q31234, 3Q31240, 3Q31301, 3Q31302, 3Q31303, 3Q31364, 3Q31404, 3Q31405, 3Q31452, 3Q31547, 3Q31548, 3Q31550, 3Q31557, 3Q31558, 3Q31559, 3Q31625, 3Q31626, 3Q31627, 3Q31628, 3Q31744, 3Q31745, 3Q31807, 3Q31808, 3Q31934, 3Q31935, 3Q31936, 3Q31937, 3Q32028, 3Q32029, 3Q32036, 3Q32134, 3Q32135, 3Q32136, 3Q32252, 3Q32254, 3Q32305, 3Q32306, 3Q32346, 3Q32445, 3Q32446, 3Q32453, 3Q32454, 3Q32509, 3Q32510, 3Q32511, 3Q32604, 3Q32746, 3Q32747, 3Q32748, 3Q32749, 3Q32750, 3Q32751, 3Q32752, 3Q32753, 3Q32802, 3Q32803, 3Q32804, 3Q32805, 3Q32806, 3Q32906, 3Q32907, 3Q32951, 3Q33005, 3Q33007, 3Q33056, 3Q33125, 3Q33126, 3Q33127, 3Q33201, 3Q33202, 3Q33209, 3Q33525, 3Q33526, 3Q33564, 3Q33565, 3Q33617, 3Q33618, 3Q33619, 3Q33620, 3Q33622, 3Q33623, 3Q33830, 3Q33831, 3Q33832, 3Q33833, 3Q33834, 3Q33835, 3Q33837, 3Q33930, 3Q33931, 3Q33932, 3Q33933, 3Q33934, 3Q33936, 3Q34128, 3Q34130, 3Q34131, 3Q34132, 3Q34134, 3Q34240, 3Q34241, 3Q34242, 3Q34244, 3Q34245, 3Q34337, 3Q34338, 3Q34339, 3Q34340, 3Q34341, 3Q34342, 3Q34420, 3Q34421, 3Q34422, 3Q34441, 3Q34508, 3Q34509, 3Q34510, 3Q34511, 3Q34512, 3Q34639, 3Q34641, 3Q34733, 3Q34736, 3Q34804, 3Q34823, 3Q34909, 3Q34910, 3Q35033, 3Q35034, 3Q35110, 3Q35112, 3Q35202, 3Q35206, 3Q35416, 3Q35417, 3Q35614, 3Q35637, 3Q35702, 3Q35756, 3Q35810, 3Q35902, 3R00215, 3R00317, 3R00320, 3R00403, 3R00430, 3R00432, 3R00434, 3R00640, 3R00642, 3R00643, 3R00645, 3R00840, 3R00920, 3R00921, 3R01131, 3R01338, 3R01509, 3R01930, 3R01931, 3R02233, 3Q25121, 3Q25328, 3Q25346, 3Q25841, 3Q26040, 3Q26347, 3Q26615, 3Q26616, 3Q28814, 3Q29032, 3Q30035, 3Q30248, 3Q30258, 3Q31137, 3Q31549, 3Q32253, 3Q32905, 3Q33124, 3Q34129, 3Q34803, 3Q35613, 3R00922, 3R01513, 3R02827/ 10757770635921, 10757770607492, 10757770607515, 10757770607539, 10757770607553, 10757770607577, 10757770607591, 10757770607614, 10757770607638, 10757770607652, 10757770607676, 10757770607683, 10757770607690, 10757770607706, 10757770607713, 10757770607720, 10757770607737, 10757770607744, 10757770607751, 10757770607768, 10757770607775, 10757770607782, 10757770607799, 10757770607805, 10757770607812, 10757770607829, 10757770607836, 10757770607843, 10757770607850, 10757770607867, 10757770607874, 10757770673930, 10757770607898, 10757770607904, 10757770607911, 10757770607928, 10757770607935, 10757770607942, 10757770607959, 10757770607966, 10757770607973, 10757770607980, 10757770607997, 10757770608000, 10757770608017, 10757770608024, 10757770608031, 10757770608048, 10757770608055, 10757770608062, 10757770608079, 10757770608093, 10757770608116, 10757770608130, 10757770608154; enVista Aspire IOL (EAU)/3Q24836, 3Q25105, 3Q25141, 3Q25142, 3Q25144, 3Q25145, 3Q25146, 3Q25223, 3Q25224, 3Q25225, 3Q25226, 3Q25227, 3Q25301, 3Q25302, 3Q25303, 3Q25304, 3Q25312, 3Q25313, 3Q25314, 3Q25315, 3Q25316, 3Q25317, 3Q25415, 3Q25416, 3Q25417, 3Q25444, 3Q25540, 3Q25542, 3Q25543, 3Q25623, 3Q25624, 3Q25627, 3Q25829, 3Q25830, 3Q25831, 3Q26401, 3Q26403, 3Q26404, 3Q26416, 3Q26417, 3Q26501, 3Q26502, 3Q26537, 3Q26541, 3Q26543, 3Q26607, 3Q26608, 3Q26611, 3Q26924, 3Q26925, 3Q26926, 3Q26941, 3Q26942, 3Q26943, 3Q26944, 3Q27245, 3Q27246, 3Q27247, 3Q27266, 3Q27267, 3Q27304, 3Q27305, 3Q27306, 3Q27307, 3Q27348, 3Q27349, 3Q27513, 3Q27514, 3Q27515, 3Q27606, 3Q27714, 3Q27715, 3Q27716, 3Q27718, 3Q27719, 3Q27802, 3Q27803, 3Q27804, 3Q27805, 3Q27933, 3Q27934, 3Q27935, 3Q27936, 3Q27937, 3Q28049, 3Q28050, 3Q28051, 3Q28213, 3Q28214, 3Q28216, 3Q28705, 3Q28706, 3Q28846, 3Q28847, 3Q28849, 3Q28850, 3Q28851, 3Q28852, 3Q28940, 3Q29002, 3Q29003, 3Q29004, 3Q29005, 3Q29107, 3Q29108, 3Q29155, 3Q29156, 3Q29157, 3Q29158, 3Q29251, 3Q29252, 3Q29265, 3Q29267, 3Q29268, 3Q29321, 3Q29322, 3Q29323, 3Q29324, 3Q29416, 3Q29417, 3Q29418, 3Q29419, 3Q29420, 3Q29539, 3Q29540, 3Q29541, 3Q29542, 3Q29543, 3Q29544, 3Q29601, 3Q29602, 3Q29603, 3Q29604, 3Q29716, 3Q29717, 3Q29718, 3Q29719, 3Q29721, 3Q29722, 3Q29819, 3Q29820, 3Q29821, 3Q29907, 3Q29908, 3Q30014, 3Q30015, 3Q30016, 3Q30108, 3Q30109, 3Q30110, 3Q30323, 3Q30324, 3Q30408, 3Q30409, 3Q30410, 3Q30510, 3Q30604, 3Q30605, 3Q30606, 3Q30712, 3Q30713, 3Q30714, 3Q30715, 3Q30716, 3Q30829, 3Q30830, 3Q31001, 3Q31002, 3Q31003, 3Q31004, 3Q31022, 3Q31127, 3Q31128, 3Q31129, 3Q31130, 3Q31159, 3Q31160, 3Q31161, 3Q31235, 3Q31333, 3Q31334, 3Q31335, 3Q31336, 3Q31337, 3Q31338, 3Q31409, 3Q31410, 3Q31416, 3Q31417, 3Q31505, 3Q31649, 3Q31709, 3Q31742, 3Q31743, 3Q31753, 3Q31805, 3Q31822, 3Q31902, 3Q31939, 3Q32026, 3Q32101, 3Q32153, 3Q32154, 3Q32415, 3Q32416, 3Q32505, 3Q32601, 3Q32602, 3Q32613, 3Q32617, 3Q32950, 3Q33055, 3Q33502, 3Q33523, 3Q33563, 3Q33601, 3Q33602, 3Q33621, 3Q33704, 3Q33740, 3Q35114, 3Q35231, 3Q35232, 3Q25102, 3Q25414, 3Q26402, 3Q26540, 3Q26542, 3Q26609, 3Q26610, 3Q27227, 3Q27717, 3Q27801, 3Q27931, 3Q27932, 3Q28215, 3Q28848, 3Q29159, 3Q29256, 3Q29325, 3Q29421, 3Q29605, 3Q29720, 3Q29906, 3Q30013, 3Q30254, 3Q30255, 3Q30511, 3Q30512, 3Q30821, 3Q30828, 3Q31037, 3Q31236, 3Q31504, 3Q31806, 3Q32027, 3Q32504, 3Q32507, 3Q32825, 3Q33006, 3Q33110, 3Q34643, 3Q34818/ 10757770608277, 10757770608284, 10757770608291, 10757770608307, 10757770608314, 10757770608321, 10757770608338, 10757770608345, 10757770608352, 10757770608369, 10757770608376, 10757770608383, 10757770608390, 10757770608406, 10757770608413, 10757770608420, 10757770608437, 10757770608444, 10757770608451, 10757770608468, 10757770608475, 10757770608482, 10757770608499, 10757770608505, 10757770608512, 10757770608529, 10757770608536, 10757770608543, 10757770608550, 10757770608567, 10757770608574, 10757770608581, 10757770608598, 10757770608604, 10757770608611, 10757770608628, 10757770608635, 10757770608642, 10757770608659, 10757770608666, 10757770608673, 10757770608680, 10757770608697, 10757770608703, 10757770608710, 10757770608727, 10757770608734, 10757770608741, 10757770608758, 10757770608765, 10757770608772, 10757770608789, 10757770608796, 10757770608802, 10757770608819, 10757770608826, 10757770608833; enVista Monofocal Toric IOL (ETEU)/3Q24827, 3Q25022, 3Q25243, 3Q25248, 3Q25250, 3Q25252, 3Q25402, 3Q25403, 3Q25428, 3Q25429, 3Q25430, 3Q25434, 3Q25435, 3Q25436, 3Q25437, 3Q25438, 3Q25441, 3Q25528, 3Q25532, 3Q25538, 3Q25552, 3Q25553, 3Q25556, 3Q25564, 3Q25739, 3Q25957, 3Q26018, 3Q26028, 3Q26065, 3Q26218, 3Q26242, 3Q26249, 3Q26349, 3Q26351, 3Q26532, 3Q26533, 3Q26649, 3Q26654, 3Q26656, 3Q26657, 3Q26825, 3Q26827, 3Q26828, 3Q26830, 3Q26831, 3Q26932, 3Q27228, 3Q27229, 3Q27238, 3Q27239, 3Q27241, 3Q27257, 3Q27259, 3Q27345, 3Q27433, 3Q27434, 3Q27436, 3Q27437, 3Q27459, 3Q27632, 3Q27806, 3Q27921, 3Q27922, 3Q27924, 3Q28024, 3Q28025, 3Q28027, 3Q28028, 3Q28029, 3Q28030, 3Q28032, 3Q28142, 3Q28143, 3Q28145, 3Q28146, 3Q28148, 3Q28149, 3Q28150, 3Q28238, 3Q28240, 3Q28925, 3Q28927, 3Q28928, 3Q28929, 3Q29143, 3Q29144, 3Q29145, 3Q29160, 3Q29161, 3Q29162, 3Q29163, 3Q29168, 3Q29170, 3Q29315, 3Q29316, 3Q29318, 3Q29430, 3Q29431, 3Q29434, 3Q29435, 3Q29436, 3Q29528, 3Q29531, 3Q29536, 3Q29652, 3Q29659, 3Q29660, 3Q29729, 3Q29730, 3Q29822, 3Q29823, 3Q29927, 3Q29929, 3Q30036, 3Q30038, 3Q30039, 3Q30040, 3Q30041, 3Q30146, 3Q30229, 3Q30231, 3Q30449, 3Q30451, 3Q30531, 3Q30650, 3Q30656, 3Q30659, 3Q30750, 3Q30752, 3Q30754, 3Q30804, 3Q30808, 3Q30935, 3Q31049, 3Q31052, 3Q31119, 3Q31120, 3Q31122, 3Q31124, 3Q31126, 3Q31306, 3Q31367, 3Q31453, 3Q31457, 3Q31551, 3Q31554, 3Q31629, 3Q31630, 3Q31635, 3Q31847, 3Q31852, 3Q31853, 3Q31870, 3Q31872, 3Q31940, 3Q31941, 3Q31942, 3Q32112, 3Q32114, 3Q32333, 3Q32447, 3Q32532, 3Q32633, 3Q32639, 3Q32852, 3Q32853, 3Q32854, 3Q33534, 3Q33627, 3Q33750, 3Q33942, 3Q34137, 3Q34138, 3Q34139, 3Q34140, 3Q34143, 3Q34255, 3Q34345, 3Q34451, 3Q34738, 3Q34743, 3Q34810, 3Q34813, 3Q35310, 3Q35542, 3Q35546, 3Q35755, 3Q35827, 3Q35924, 3R00428, 3R00632, 3R00928, 3R00930, 3R02340, 3R02573, 3R02731, 3R02837, 3R03436, 3R03939, 3Q24718, 3Q24719, 3Q24723, 3Q24724, 3Q24825, 3Q24826, 3Q24828, 3Q25023, 3Q25024, 3Q25042, 3Q25133, 3Q25134, 3Q25135, 3Q25136, 3Q25137, 3Q25240, 3Q25241, 3Q25242, 3Q25244, 3Q25245, 3Q25246, 3Q25247, 3Q25249, 3Q25251, 3Q25253, 3Q25254, 3Q25255, 3Q25256, 3Q25257, 3Q25336, 3Q25337, 3Q25338, 3Q25339, 3Q25340, 3Q25341, 3Q25342, 3Q25343, 3Q25431, 3Q25432, 3Q25433, 3Q25439, 3Q25440, 3Q25442, 3Q25443, 3Q25519, 3Q25520, 3Q25521, 3Q25523, 3Q25524, 3Q25525, 3Q25526, 3Q25527, 3Q25529, 3Q25530, 3Q25531, 3Q25533, 3Q25536, 3Q25537, 3Q25539, 3Q25544, 3Q25554, 3Q25555, 3Q25561, 3Q25562, 3Q25563, 3Q25565, 3Q25566, 3Q25635, 3Q25637, 3Q25645, 3Q25646, 3Q25734, 3Q25956, 3Q26001, 3Q26002, 3Q26019, 3Q26020, 3Q26021, 3Q26022, 3Q26023, 3Q26024, 3Q26025, 3Q26026, 3Q26027, 3Q26029, 3Q26030, 3Q26031, 3Q26032, 3Q26033, 3Q26034, 3Q26035, 3Q26064, 3Q26066, 3Q26067, 3Q26068, 3Q26219, 3Q26243, 3Q26244, 3Q26245, 3Q26246, 3Q26247, 3Q26248, 3Q26250, 3Q26251, 3Q26252, 3Q26253, 3Q26254, 3Q26335, 3Q26336, 3Q26337, 3Q26338, 3Q26339, 3Q26340, 3Q26341, 3Q26342, 3Q26343, 3Q26344, 3Q26345, 3Q26350, 3Q26352, 3Q26353, 3Q26530, 3Q26531, 3Q26534, 3Q26535, 3Q26536, 3Q26648, 3Q26650, 3Q26651, 3Q26652, 3Q26653, 3Q26655, 3Q26658, 3Q26826, 3Q26829, 3Q26832, 3Q26931, 3Q26933, 3Q26934, 3Q26935, 3Q26936, 3Q26937, 3Q26938, 3Q26939, 3Q26940, 3Q27231, 3Q27232, 3Q27233, 3Q27234, 3Q27235, 3Q27237, 3Q27240, 3Q27242, 3Q27258, 3Q27338, 3Q27339, 3Q27340, 3Q27341, 3Q27342, 3Q27344, 3Q27346, 3Q27430, 3Q27431, 3Q27432, 3Q27435, 3Q27438, 3Q27439, 3Q27440, 3Q27441, 3Q27460, 3Q27525, 3Q27526, 3Q27527, 3Q27621, 3Q27622, 3Q27623, 3Q27630, 3Q27631, 3Q27633, 3Q27634, 3Q27635, 3Q27740, 3Q27741, 3Q27915, 3Q27916, 3Q27917, 3Q27918, 3Q27919, 3Q27920, 3Q27923, 3Q27925, 3Q28023, 3Q28026, 3Q28031, 3Q28033, 3Q28140, 3Q28141, 3Q28144, 3Q28147, 3Q28151, 3Q28156, 3Q28235, 3Q28236, 3Q28237, 3Q28239, 3Q28715, 3Q28716, 3Q28717, 3Q28832, 3Q28833, 3Q28834, 3Q28835, 3Q28924, 3Q28926, 3Q28930, 3Q28931, 3Q28932, 3Q28933, 3Q29035, 3Q29036, 3Q29037, 3Q29038, 3Q29039, 3Q29146, 3Q29147, 3Q29148, 3Q29149, 3Q29164, 3Q29165, 3Q29169, 3Q29171, 3Q29172, 3Q29173, 3Q29314, 3Q29317, 3Q29427, 3Q29428, 3Q29429, 3Q29432, 3Q29433, 3Q29437, 3Q29527, 3Q29529, 3Q29530, 3Q29532, 3Q29533, 3Q29534, 3Q29535, 3Q29650, 3Q29651, 3Q29653, 3Q29654, 3Q29655, 3Q29656, 3Q29657, 3Q29658, 3Q29728, 3Q29731, 3Q29824, 3Q2...

Label field

Details supplied by the agency

Lot, code or applicability

Description/Lots/UDI-DI: enVista Monofocal IOL (EEU)/3Q25120, 3Q25326, 3Q25327, 3Q25347, 3Q25348, 3Q25425, 3Q25426, 3Q25427, 3Q25507, 3Q25508, 3Q25509, 3Q25510, 3Q25511, 3Q25548, 3Q25549, 3Q25550, 3Q25628, 3Q25632, 3Q25730, 3Q25731, 3Q25840, 3Q25843, 3Q25934, 3Q25935, 3Q25936, 3Q25937, 3Q25938, 3Q25939, 3Q25940, 3Q25941, 3Q25942, 3Q25943, 3Q25944, 3Q26009, 3Q26010, 3Q26041, 3Q26042, 3Q26043, 3Q26044, 3Q26069, 3Q26070, 3Q26071, 3Q26072, 3Q26119, 3Q26120, 3Q26121, 3Q26122, 3Q26123, 3Q26202, 3Q26203, 3Q26204, 3Q26220, 3Q26255, 3Q26262, 3Q26301, 3Q26305, 3Q26306, 3Q26328, 3Q26329, 3Q26330, 3Q26331, 3Q26332, 3Q26333, 3Q26334, 3Q26348, 3Q26422, 3Q26424, 3Q26425, 3Q26444, 3Q26445, 3Q26446, 3Q26520, 3Q26521, 3Q26522, 3Q26614, 3Q26617, 3Q26618, 3Q26681, 3Q26682, 3Q26683, 3Q26684, 3Q26733, 3Q26734, 3Q26735, 3Q26747, 3Q26801, 3Q26802, 3Q26833, 3Q26834, 3Q26835, 3Q26836, 3Q26911, 3Q26912, 3Q26913, 3Q26914, 3Q26916, 3Q27101, 3Q27102, 3Q27103, 3Q27104, 3Q27201, 3Q27202, 3Q27203, 3Q27226, 3Q27253, 3Q27254, 3Q27255, 3Q27336, 3Q27337, 3Q27450, 3Q27451, 3Q27452, 3Q27453, 3Q27454, 3Q27455, 3Q27520, 3Q27620, 3Q27808, 3Q27809, 3Q27928, 3Q27929, 3Q27930, 3Q28021, 3Q28022, 3Q28101, 3Q28137, 3Q28138, 3Q28139, 3Q28712, 3Q28713, 3Q28714, 3Q28812, 3Q28813, 3Q28815, 3Q28816, 3Q28913, 3Q28914, 3Q28915, 3Q29033, 3Q29034, 3Q29140, 3Q29141, 3Q29142, 3Q29215, 3Q29216, 3Q29217, 3Q29218, 3Q29255, 3Q29319, 3Q29320, 3Q29422, 3Q29423, 3Q29424, 3Q29425, 3Q29524, 3Q29526, 3Q29537, 3Q29646, 3Q29647, 3Q29648, 3Q29649, 3Q29723, 3Q29724, 3Q29725, 3Q29726, 3Q29727, 3Q29817, 3Q29818, 3Q29904, 3Q29905, 3Q29924, 3Q30032, 3Q30033, 3Q30034, 3Q30141, 3Q30142, 3Q30143, 3Q30144, 3Q30145, 3Q30215, 3Q30250, 3Q30253, 3Q30325, 3Q30326, 3Q30442, 3Q30443, 3Q30444, 3Q30525, 3Q30526, 3Q30527, 3Q30528, 3Q30529, 3Q30602, 3Q30638, 3Q30639, 3Q30640, 3Q30641, 3Q30644, 3Q30645, 3Q30833, 3Q30834, 3Q30835, 3Q30836, 3Q30928, 3Q30929, 3Q30930, 3Q30948, 3Q30949, 3Q31005, 3Q31044, 3Q31045, 3Q31136, 3Q31138, 3Q31140, 3Q31233, 3Q31234, 3Q31240, 3Q31301, 3Q31302, 3Q31303, 3Q31364, 3Q31404, 3Q31405, 3Q31452, 3Q31547, 3Q31548, 3Q31550, 3Q31557, 3Q31558, 3Q31559, 3Q31625, 3Q31626, 3Q31627, 3Q31628, 3Q31744, 3Q31745, 3Q31807, 3Q31808, 3Q31934, 3Q31935, 3Q31936, 3Q31937, 3Q32028, 3Q32029, 3Q32036, 3Q32134, 3Q32135, 3Q32136, 3Q32252, 3Q32254, 3Q32305, 3Q32306, 3Q32346, 3Q32445, 3Q32446, 3Q32453, 3Q32454, 3Q32509, 3Q32510, 3Q32511, 3Q32604, 3Q32746, 3Q32747, 3Q32748, 3Q32749, 3Q32750, 3Q32751, 3Q32752, 3Q32753, 3Q32802, 3Q32803, 3Q32804, 3Q32805, 3Q32806, 3Q32906, 3Q32907, 3Q32951, 3Q33005, 3Q33007, 3Q33056, 3Q33125, 3Q33126, 3Q33127, 3Q33201, 3Q33202, 3Q33209, 3Q33525, 3Q33526, 3Q33564, 3Q33565, 3Q33617, 3Q33618, 3Q33619, 3Q33620, 3Q33622, 3Q33623, 3Q33830, 3Q33831, 3Q33832, 3Q33833, 3Q33834, 3Q33835, 3Q33837, 3Q33930, 3Q33931, 3Q33932, 3Q33933, 3Q33934, 3Q33936, 3Q34128, 3Q34130, 3Q34131, 3Q34132, 3Q34134, 3Q34240, 3Q34241, 3Q34242, 3Q34244, 3Q34245, 3Q34337, 3Q34338, 3Q34339, 3Q34340, 3Q34341, 3Q34342, 3Q34420, 3Q34421, 3Q34422, 3Q34441, 3Q34508, 3Q34509, 3Q34510, 3Q34511, 3Q34512, 3Q34639, 3Q34641, 3Q34733, 3Q34736, 3Q34804, 3Q34823, 3Q34909, 3Q34910, 3Q35033, 3Q35034, 3Q35110, 3Q35112, 3Q35202, 3Q35206, 3Q35416, 3Q35417, 3Q35614, 3Q35637, 3Q35702, 3Q35756, 3Q35810, 3Q35902, 3R00215, 3R00317, 3R00320, 3R00403, 3R00430, 3R00432, 3R00434, 3R00640, 3R00642, 3R00643, 3R00645, 3R00840, 3R00920, 3R00921, 3R01131, 3R01338, 3R01509, 3R01930, 3R01931, 3R02233, 3Q25121, 3Q25328, 3Q25346, 3Q25841, 3Q26040, 3Q26347, 3Q26615, 3Q26616, 3Q28814, 3Q29032, 3Q30035, 3Q30248, 3Q30258, 3Q31137, 3Q31549, 3Q32253, 3Q32905, 3Q33124, 3Q34129, 3Q34803, 3Q35613, 3R00922, 3R01513, 3R02827/ 10757770635921, 10757770607492, 10757770607515, 10757770607539, 10757770607553, 10757770607577, 10757770607591, 10757770607614, 10757770607638, 10757770607652, 10757770607676, 10757770607683, 10757770607690, 10757770607706, 10757770607713, 10757770607720, 10757770607737, 10757770607744, 10757770607751, 10757770607768, 10757770607775, 10757770607782, 10757770607799, 10757770607805, 10757770607812, 10757770607829, 10757770607836, 10757770607843, 10757770607850, 10757770607867, 10757770607874, 10757770673930, 10757770607898, 10757770607904, 10757770607911, 10757770607928, 10757770607935, 10757770607942, 10757770607959, 10757770607966, 10757770607973, 10757770607980, 10757770607997, 10757770608000, 10757770608017, 10757770608024, 10757770608031, 10757770608048, 10757770608055, 10757770608062, 10757770608079, 10757770608093, 10757770608116, 10757770608130, 10757770608154; enVista Aspire IOL (EAU)/3Q24836, 3Q25105, 3Q25141, 3Q25142, 3Q25144, 3Q25145, 3Q25146, 3Q25223, 3Q25224, 3Q25225, 3Q25226, 3Q25227, 3Q25301, 3Q25302, 3Q25303, 3Q25304, 3Q25312, 3Q25313, 3Q25314, 3Q25315, 3Q25316, 3Q25317, 3Q25415, 3Q25416, 3Q25417, 3Q25444, 3Q25540, 3Q25542, 3Q25543, 3Q25623, 3Q25624, 3Q25627, 3Q25829, 3Q25830, 3Q25831, 3Q26401, 3Q26403, 3Q26404, 3Q26416, 3Q26417, 3Q26501, 3Q26502, 3Q26537, 3Q26541, 3Q26543, 3Q26607, 3Q26608, 3Q26611, 3Q26924, 3Q26925, 3Q26926, 3Q26941, 3Q26942, 3Q26943, 3Q26944, 3Q27245, 3Q27246, 3Q27247, 3Q27266, 3Q27267, 3Q27304, 3Q27305, 3Q27306, 3Q27307, 3Q27348, 3Q27349, 3Q27513, 3Q27514, 3Q27515, 3Q27606, 3Q27714, 3Q27715, 3Q27716, 3Q27718, 3Q27719, 3Q27802, 3Q27803, 3Q27804, 3Q27805, 3Q27933, 3Q27934, 3Q27935, 3Q27936, 3Q27937, 3Q28049, 3Q28050, 3Q28051, 3Q28213, 3Q28214, 3Q28216, 3Q28705, 3Q28706, 3Q28846, 3Q28847, 3Q28849, 3Q28850, 3Q28851, 3Q28852, 3Q28940, 3Q29002, 3Q29003, 3Q29004, 3Q29005, 3Q29107, 3Q29108, 3Q29155, 3Q29156, 3Q29157, 3Q29158, 3Q29251, 3Q29252, 3Q29265, 3Q29267, 3Q29268, 3Q29321, 3Q29322, 3Q29323, 3Q29324, 3Q29416, 3Q29417, 3Q29418, 3Q29419, 3Q29420, 3Q29539, 3Q29540, 3Q29541, 3Q29542, 3Q29543, 3Q29544, 3Q29601, 3Q29602, 3Q29603, 3Q29604, 3Q29716, 3Q29717, 3Q29718, 3Q29719, 3Q29721, 3Q29722, 3Q29819, 3Q29820, 3Q29821, 3Q29907, 3Q29908, 3Q30014, 3Q30015, 3Q30016, 3Q30108, 3Q30109, 3Q30110, 3Q30323, 3Q30324, 3Q30408, 3Q30409, 3Q30410, 3Q30510, 3Q30604, 3Q30605, 3Q30606, 3Q30712, 3Q30713, 3Q30714, 3Q30715, 3Q30716, 3Q30829, 3Q30830, 3Q31001, 3Q31002, 3Q31003, 3Q31004, 3Q31022, 3Q31127, 3Q31128, 3Q31129, 3Q31130, 3Q31159, 3Q31160, 3Q31161, 3Q31235, 3Q31333, 3Q31334, 3Q31335, 3Q31336, 3Q31337, 3Q31338, 3Q31409, 3Q31410, 3Q31416, 3Q31417, 3Q31505, 3Q31649, 3Q31709, 3Q31742, 3Q31743, 3Q31753, 3Q31805, 3Q31822, 3Q31902, 3Q31939, 3Q32026, 3Q32101, 3Q32153, 3Q32154, 3Q32415, 3Q32416, 3Q32505, 3Q32601, 3Q32602, 3Q32613, 3Q32617, 3Q32950, 3Q33055, 3Q33502, 3Q33523, 3Q33563, 3Q33601, 3Q33602, 3Q33621, 3Q33704, 3Q33740, 3Q35114, 3Q35231, 3Q35232, 3Q25102, 3Q25414, 3Q26402, 3Q26540, 3Q26542, 3Q26609, 3Q26610, 3Q27227, 3Q27717, 3Q27801, 3Q27931, 3Q27932, 3Q28215, 3Q28848, 3Q29159, 3Q29256, 3Q29325, 3Q29421, 3Q29605, 3Q29720, 3Q29906, 3Q30013, 3Q30254, 3Q30255, 3Q30511, 3Q30512, 3Q30821, 3Q30828, 3Q31037, 3Q31236, 3Q31504, 3Q31806, 3Q32027, 3Q32504, 3Q32507, 3Q32825, 3Q33006, 3Q33110, 3Q34643, 3Q34818/ 10757770608277, 10757770608284, 10757770608291, 10757770608307, 10757770608314, 10757770608321, 10757770608338, 10757770608345, 10757770608352, 10757770608369, 10757770608376, 10757770608383, 10757770608390, 10757770608406, 10757770608413, 10757770608420, 10757770608437, 10757770608444, 10757770608451, 10757770608468, 10757770608475, 10757770608482, 10757770608499, 10757770608505, 10757770608512, 10757770608529, 10757770608536, 10757770608543, 10757770608550, 10757770608567, 10757770608574, 10757770608581, 10757770608598, 10757770608604, 10757770608611, 10757770608628, 10757770608635, 10757770608642, 10757770608659, 10757770608666, 10757770608673, 10757770608680, 10757770608697, 10757770608703, 10757770608710, 10757770608727, 10757770608734, 10757770608741, 10757770608758, 10757770608765, 10757770608772, 10757770608789, 10757770608796, 10757770608802, 10757770608819, 10757770608826, 10757770608833; enVista Monofocal Toric IOL (ETEU)/3Q24827, 3Q25022, 3Q25243, 3Q25248, 3Q25250, 3Q25252, 3Q25402, 3Q25403, 3Q25428, 3Q25429, 3Q25430, 3Q25434, 3Q25435, 3Q25436, 3Q25437, 3Q25438, 3Q25441, 3Q25528, 3Q25532, 3Q25538, 3Q25552, 3Q25553, 3Q25556, 3Q25564, 3Q25739, 3Q25957, 3Q26018, 3Q26028, 3Q26065, 3Q26218, 3Q26242, 3Q26249, 3Q26349, 3Q26351, 3Q26532, 3Q26533, 3Q26649, 3Q26654, 3Q26656, 3Q26657, 3Q26825, 3Q26827, 3Q26828, 3Q26830, 3Q26831, 3Q26932, 3Q27228, 3Q27229, 3Q27238, 3Q27239, 3Q27241, 3Q27257, 3Q27259, 3Q27345, 3Q27433, 3Q27434, 3Q27436, 3Q27437, 3Q27459, 3Q27632, 3Q27806, 3Q27921, 3Q27922, 3Q27924, 3Q28024, 3Q28025, 3Q28027, 3Q28028, 3Q28029, 3Q28030, 3Q28032, 3Q28142, 3Q28143, 3Q28145, 3Q28146, 3Q28148, 3Q28149, 3Q28150, 3Q28238, 3Q28240, 3Q28925, 3Q28927, 3Q28928, 3Q28929, 3Q29143, 3Q29144, 3Q29145, 3Q29160, 3Q29161, 3Q29162, 3Q29163, 3Q29168, 3Q29170, 3Q29315, 3Q29316, 3Q29318, 3Q29430, 3Q29431, 3Q29434, 3Q29435, 3Q29436, 3Q29528, 3Q29531, 3Q29536, 3Q29652, 3Q29659, 3Q29660, 3Q29729, 3Q29730, 3Q29822, 3Q29823, 3Q29927, 3Q29929, 3Q30036, 3Q30038, 3Q30039, 3Q30040, 3Q30041, 3Q30146, 3Q30229, 3Q30231, 3Q30449, 3Q30451, 3Q30531, 3Q30650, 3Q30656, 3Q30659, 3Q30750, 3Q30752, 3Q30754, 3Q30804, 3Q30808, 3Q30935, 3Q31049, 3Q31052, 3Q31119, 3Q31120, 3Q31122, 3Q31124, 3Q31126, 3Q31306, 3Q31367, 3Q31453, 3Q31457, 3Q31551, 3Q31554, 3Q31629, 3Q31630, 3Q31635, 3Q31847, 3Q31852, 3Q31853, 3Q31870, 3Q31872, 3Q31940, 3Q31941, 3Q31942, 3Q32112, 3Q32114, 3Q32333, 3Q32447, 3Q32532, 3Q32633, 3Q32639, 3Q32852, 3Q32853, 3Q32854, 3Q33534, 3Q33627, 3Q33750, 3Q33942, 3Q34137, 3Q34138, 3Q34139, 3Q34140, 3Q34143, 3Q34255, 3Q34345, 3Q34451, 3Q34738, 3Q34743, 3Q34810, 3Q34813, 3Q35310, 3Q35542, 3Q35546, 3Q35755, 3Q35827, 3Q35924, 3R00428, 3R00632, 3R00928, 3R00930, 3R02340, 3R02573, 3R02731, 3R02837, 3R03436, 3R03939, 3Q24718, 3Q24719, 3Q24723, 3Q24724, 3Q24825, 3Q24826, 3Q24828, 3Q25023, 3Q25024, 3Q25042, 3Q25133, 3Q25134, 3Q25135, 3Q25136, 3Q25137, 3Q25240, 3Q25241, 3Q25242, 3Q25244, 3Q25245, 3Q25246, 3Q25247, 3Q25249, 3Q25251, 3Q25253, 3Q25254, 3Q25255, 3Q25256, 3Q25257, 3Q25336, 3Q25337, 3Q25338, 3Q25339, 3Q25340, 3Q25341, 3Q25342, 3Q25343, 3Q25431, 3Q25432, 3Q25433, 3Q25439, 3Q25440, 3Q25442, 3Q25443, 3Q25519, 3Q25520, 3Q25521, 3Q25523, 3Q25524, 3Q25525, 3Q25526, 3Q25527, 3Q25529, 3Q25530, 3Q25531, 3Q25533, 3Q25536, 3Q25537, 3Q25539, 3Q25544, 3Q25554, 3Q25555, 3Q25561, 3Q25562, 3Q25563, 3Q25565, 3Q25566, 3Q25635, 3Q25637, 3Q25645, 3Q25646, 3Q25734, 3Q25956, 3Q26001, 3Q26002, 3Q26019, 3Q26020, 3Q26021, 3Q26022, 3Q26023, 3Q26024, 3Q26025, 3Q26026, 3Q26027, 3Q26029, 3Q26030, 3Q26031, 3Q26032, 3Q26033, 3Q26034, 3Q26035, 3Q26064, 3Q26066, 3Q26067, 3Q26068, 3Q26219, 3Q26243, 3Q26244, 3Q26245, 3Q26246, 3Q26247, 3Q26248, 3Q26250, 3Q26251, 3Q26252, 3Q26253, 3Q26254, 3Q26335, 3Q26336, 3Q26337, 3Q26338, 3Q26339, 3Q26340, 3Q26341, 3Q26342, 3Q26343, 3Q26344, 3Q26345, 3Q26350, 3Q26352, 3Q26353, 3Q26530, 3Q26531, 3Q26534, 3Q26535, 3Q26536, 3Q26648, 3Q26650, 3Q26651, 3Q26652, 3Q26653, 3Q26655, 3Q26658, 3Q26826, 3Q26829, 3Q26832, 3Q26931, 3Q26933, 3Q26934, 3Q26935, 3Q26936, 3Q26937, 3Q26938, 3Q26939, 3Q26940, 3Q27231, 3Q27232, 3Q27233, 3Q27234, 3Q27235, 3Q27237, 3Q27240, 3Q27242, 3Q27258, 3Q27338, 3Q27339, 3Q27340, 3Q27341, 3Q27342, 3Q27344, 3Q27346, 3Q27430, 3Q27431, 3Q27432, 3Q27435, 3Q27438, 3Q27439, 3Q27440, 3Q27441, 3Q27460, 3Q27525, 3Q27526, 3Q27527, 3Q27621, 3Q27622, 3Q27623, 3Q27630, 3Q27631, 3Q27633, 3Q27634, 3Q27635, 3Q27740, 3Q27741, 3Q27915, 3Q27916, 3Q27917, 3Q27918, 3Q27919, 3Q27920, 3Q27923, 3Q27925, 3Q28023, 3Q28026, 3Q28031, 3Q28033, 3Q28140, 3Q28141, 3Q28144, 3Q28147, 3Q28151, 3Q28156, 3Q28235, 3Q28236, 3Q28237, 3Q28239, 3Q28715, 3Q28716, 3Q28717, 3Q28832, 3Q28833, 3Q28834, 3Q28835, 3Q28924, 3Q28926, 3Q28930, 3Q28931, 3Q28932, 3Q28933, 3Q29035, 3Q29036, 3Q29037, 3Q29038, 3Q29039, 3Q29146, 3Q29147, 3Q29148, 3Q29149, 3Q29164, 3Q29165, 3Q29169, 3Q29171, 3Q29172, 3Q29173, 3Q29314, 3Q29317, 3Q29427, 3Q29428, 3Q29429, 3Q29432, 3Q29433, 3Q29437, 3Q29527, 3Q29529, 3Q29530, 3Q29532, 3Q29533, 3Q29534, 3Q29535, 3Q29650, 3Q29651, 3Q29653, 3Q29654, 3Q29655, 3Q29656, 3Q29657, 3Q29658, 3Q29728, 3Q29731, 3Q29824, 3Q2...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Worldwide distribution. US Nationwide including PR and GU, and the countries of CAN, AUS, AUT, BEL, BGR, IC, HRV, CZE, FRA, DEU, GRC, HUN, ITA, NLD, POL, PRT, ROU, ESP, GBR, NZL, HKG.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: May 14, 2025
Recall initiation date: Mar 27, 2025
Center classification date: May 2, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

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