Recall archive / FDA device enforcement
EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens. — FDA record Z-0464-2024
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 Sep 29, 2023. 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
- EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
- Reason
- Their is a potential that intraocular implant devices may not meet specifications.
- Classification
- Class II
- Recalling firm
- Staar Surgical Company
- Quantity
- 20 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0464-2024
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 | Serial/UDI: S1894967/(01)00841542118965(11)230330(17)250228(21)S1894967; S1954863/(01)00841542118958(11)230513(17)250430(21)S1954863; S1725689/(01)00841542118910(11)221103(17)241031(21)S1725689; S1725624/(01)00841542118873(11)221103(17)241031(21)S1725624; S1771602/(01)00841542118927(11)221214(17)241130(21)S1771602; S1725625/(01)00841542118873(11)221103(17)241031(21)S1725625; S1847793/(01)00841542119030(11)230218(17)250131(21)S1847793; S1725627/(01)00841542118873(11)221103(17)241031(21)S1725627; S1901889/(01)00841542118873(11)230404(17)250331(21)S1901889; S1771554/(01)00841542118873(11)221214(17)241130(21)S1771554; S1699274/(01)00841542118972(11)221016(17)240930(21)S1699274; S1877126/(01)00841542118965(11)230313(17)250228(21)S1877126; S1771633/(01)00841542119030(11)221214(17)241130(21)S1771633; S1744475/(01)00841542118910(11)221119(17)241031(21)S1744475; S1863018/(01)00841542118873(11)230302(17)250228(21)S1863018; S1734365/(01)00841542118934(11)221112(17)241031(21)S1734365; S1877112/(01)00841542118965(11)230313(17)250228(21)S1877112; S1901884/(01)00841542118873(11)230404(17)250331(21)S1901884; S1725691/(01)00841542118910(11)221103(17)241031(21)S1725691; S1892278/(01)00841542118897(11)230328(17)250228(21)S1892278 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: AR AZ CA CO CT FL GA HI ID IL IN KS KY LA MA MD MI MN MO MT NC ND NE NJ NV NY OH OK OR PA SC SD TN TX UT VA WA WI OUS: None
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Florida
- Georgia
- Hawaii
- Idaho
- Illinois
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Michigan
- Minnesota
- Missouri
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Jersey
- Nevada
- New York
- Ohio
- Oklahoma
- Pennsylvania
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
Dates in the source
- Report date
- Dec 13, 2023
- Recall initiation date
- Sep 29, 2023
- Center classification date
- Dec 1, 2023
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.