FDA Device recall Z-1291-2023
Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 17533-04 DR GROSS LPS LLC 18704-03 CATARACT SURGI CARE 18382-03 DR…
- FDA Device
- Class II
- ongoing
- Published 2023-04-05
On 2023-04-05 the FDA classified a Class II recall of Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 17533-04 DR GROSS LPS LLC 18704-03 CATARACT SURGI CARE 18382-03 DR… by Alcon Research, citing sterility; Steril surgical procedure packs contain incomplete seals.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1291-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-03-10 |
| Published | 2023-04-05 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Alcon Research |
| Distribution | AL, AR, CA, IA, ID, IN, KY, MN, NC, ND, NJ, OH, PA, TX |
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.
Identifiers
| code_info | Lot #-Pack #-Expiry Date - UDI: 158JNA 17533-04 9/30/2024 00380655132814; 158L18 18704-03 12/31/2024 003806516728…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- |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1291-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.