Recall archive / FDA device enforcement
Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 17533-04 DR GROSS LPS LLC 18704-03 CATARACT S... — FDA record Z-1291-2023
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 10, 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
- Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 17533-04 DR GROSS LPS LLC 18704-03 CATARACT SURGI CARE 18382-03 DR GEORGE ZAMBELLI BEAVER VALLEY ASC 8685-21 CATARACT PACK EYE SURGICAL CNTR OF AR 19451-02 DR ROESKE PACK INLAND VALLEY SURGERY CTR 19136-03 OCCULOPLASTIC WILMINGTON EYE 18401-03 MCGRAW SIGHTPATH MEDICAL 16032-05 MIDDLE TENNESSEE PACK SIGHTPATH MEDICAL 17570-05 CATARACT CENTURION FORT MADISON COMM HOS 19002-02 CATARACT BAPTIST HEALTH SURGERY CENTER 10560-14 CATARACT - NORTH CENTRAL 1 SIGHTPATH MED 16877-11 DR DAVID B LEACH CLEARVIEW SURGERY CENTE 19061-02 HOSLER UNIVERSITY SURGI CENTER 18911-02 MASON CATARACT THE ASC AT UNITED MEDICAL 17469-02 GENERAL CUSTOM PACK SHARP MEMORIAL HOSPI 18917-01 CATARACT 2 SURGERY CENTER OF THE TEMECUL 17115-06 DR SCZEPANSKI NORTH DAKOTA EYE CLINIC 17780-04 OPHTHALMIC TEXAS PRECISION SURGERY CENTE 2452-58 CATARACT BOLSA OUTPATIENT SURG CTR 19096-01 OPHTHALMIC EAST ALABAMA AMB SURGERY CENT 18023-04 OPHTHALMIC BRAINARD SURGERY CENTER 17039-13 EYE-Q COMPLETE CAT PAK VISION CARE SURG 5300-61 CATARACT WOODLAND MEM HOSP
- Reason
- Sterility; Steril surgical procedure packs contain incomplete seals.
- Classification
- Class II
- Recalling firm
- Alcon Research, LLC
- Quantity
- 1035 packs
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1291-2023
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 | Lot #-Pack #-Expiry Date - UDI: 158JNA 17533-04 9/30/2024 00380655132814; 158L18 18704-03 12/31/2024 00380651672833; 158JNN 18382-03 10/31/2024 00380655117132; 158L27 8685-21 09/30/2024 00380655142486; 158L24 19451-02 09/30/2024 00380655143995; 158L44 19136-03 12/31/2024 00380655129975; 158HU3 18401-03 04/30/2024 00380651651487; 158MH8 16032-05 12/31/2024 00380653369250; 158L5X 17570-05 10/31/2024 00380655129227; 158NEX 19002-02 10/31/2024 00380655120231; 158MJ3 10560-14 12/31/2024 00380655136317; 158NE8 16877-11 12/31/2024 00380655116579; 158NDK 19061-02 08/31/2024 00380655118504; 158NEM 18911-02 04/30/2024 00380651691940; 158PCP 17469-02 08/31/2024 00380653377156; 158PCD 18917-01 09/30/2024 00380651677333; 158P8K 17115-06 07/31/2024 00380651698079; 158NDC 17780-04 12/31/2024 00380651682719; 158N9Y 2452-58 12/31/2024 00380653403589; 158MFC 19096-01 10/31/2024 00380651696235; 158MHL 18023-04 10/31/2024 00380651661189; 158P7W 17039-13 08/31/2024 00380651701229; 158P97 5300-61 10/31/2024 00380651672659; |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: AL, AR, CA, IA, ID, IN, KY, MN, NC, ND, NJ, OH, PA, TX, OUS: None
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
- Apr 5, 2023
- Recall initiation date
- Mar 10, 2023
- Center classification date
- Mar 28, 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.