Alcon Custom Pak Surgical Procedure Pack: 16998-11 2519351H SALAHUDDIN 2.4 PACK FRESNO SURGICAL ...

FDA Device Recall #Z-1373-2022 — Class II — June 9, 2022

Recall Summary

Recall Number Z-1373-2022
Classification Class II — Moderate risk
Date Initiated June 9, 2022
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Alcon Research, LLC
Location Houston, TX
Product Type Devices
Quantity 320 kits

Product Description

Alcon Custom Pak Surgical Procedure Pack: 16998-11 2519351H SALAHUDDIN 2.4 PACK FRESNO SURGICAL HOSP 18392-03 14HDFF CATARACT SWAGEL WOOTTON EYE INSTITUTE 18527-03 14JM57 DOSS CATARACT ALLIANCE EYE SURG PARTNERS 11802-07 14KFAF GANS BASIC PACK NOVAMED EYE SURG CTR 11802-07 14LTRW GANS BASIC PACK NOVAMED EYE SURG CTR 11802-07 14LLME GANS BASIC PACK NOVAMED EYE SURG CTR 14429-07 14HPW3 DR SIEMINSKI CATARACT W NY CTR/AMB SVCS

Reason for Recall

Due to latex gloves being include in Custom Pak. Kits are supposed to include non-latex gloves.

Distribution Pattern

U.S.: AZ, CA, MO, and NY O.U.S.: None

Lot / Code Information

Pak #/Batch # / UDI Code 16998-11 / 2519351H / (01)10380651677385(10)2519351H(17)230331(30)3 18392-03 / 14HDFF / (01)10380651665238(10)14HDFF(17)221231(30)4 18527-03 / 14JM57 / (01)10380651684406(10)14JM57(17)240630(30)5 11802-07 / 14KFAF / (01)10380653423096(10)14KFAF(17)240430(30)5 11802-07 / 14LTRW / (01)10380653423096(10)14LTRW(17)240430(30)5 11802-07 / 14LLME / (01)10380653423096(10)14LLME(17)240430(30)5 14429-07 / 14HPW3 / (01)10380651666433(10)14HPW3(17)240229(30)6

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-1291-2023 Class II Alcon Custom Pak Surgical Procedure Pack: Pak ... Mar 10, 2023

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

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.