Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak… — Class II medical device recall Z-1291-2023
Ongoing recall by Alcon Research, LLC, reported 2023-04-05, distributed in AL, AR, CA, IA, ID, IN, KY, MN…. Sterility; Steril surgical procedure packs contain incomplete seals.
| Recall number | Z-1291-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alcon Research, LLC, Houston, TX, United States |
| Recall initiated | 2023-03-10 |
| Classified | 2023-03-28 |
| Reported by FDA | 2023-04-05 |
| Distributed | AL, AR, CA, IA, ID, IN, KY, MN, NC, ND, NJ, OH, PA, TX |
| Quantity | 1,035 packages |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00380651651487, 00380651661189, 00380651672659, 00380651672833, 00380651677333, 00380651682719, 00380651691940, 00380651696235, 00380651698079, 00380651701229, 00380653369250, 00380653377156, 00380653403589, 00380655116579, 00380655117132, 00380655118504, 00380655120231, 00380655129227, 00380655129975, 00380655132814, 00380655136317, 00380655142486, 00380655143995 |
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 for recall
Sterility; Steril surgical procedure packs contain incomplete seals.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1291-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.