Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 17533-04 DR GROSS LPS L...
FDA Device Recall #Z-1291-2023 — Class II — March 10, 2023
Recall Summary
| Recall Number | Z-1291-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 10, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Alcon Research, LLC |
| Location | Houston, TX |
| Product Type | Devices |
| Quantity | 1035 packs |
Product Description
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.
Distribution Pattern
US: AL, AR, CA, IA, ID, IN, KY, MN, NC, ND, NJ, OH, PA, TX, OUS: None
Lot / Code Information
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;
Other Recalls from Alcon Research, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1606-2024 | Class II | Various Alcon Custom Paks Surgical Procedure Pa... | Mar 15, 2024 |
| Z-1370-2024 | Class II | SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, p... | Feb 21, 2024 |
| Z-0260-2024 | Class II | Alcon Custom-Pak, Surgical Procedure Pack REF 1... | Sep 7, 2023 |
| Z-0099-2024 | Class II | Constellation Vision System, REF: 8065751150 | Aug 18, 2023 |
| Z-0354-2023 | Class II | Alcon Custom Pak Surgical Procedure Pack | Oct 31, 2022 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.