FDA Recall Open, Classified

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

Recall: Z-1373-2022 · Initiated June 9, 2022

Recall

Recall Number: Z-1373-2022
Event Number: 90437
Firm: Alcon Research, LLC
FEI Number: 1000117501
Product Code: LRO
Status: Open, Classified
Root Cause: Process control
Initiated: June 9, 2022
Address: 9965 Buffalo, Speedway Houston, TX, 77054-1309

Description

Reason

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

Action

On 06/09/2022, the firm sent an "URGENT: VOLUNTARY MEDICAL DEVICE REMOVAL" Letter via overnight mail to customer informing them that specific lots of Alcon Custom Paks were manufactured containing latex gloves and were intended to contain non-latex gloves. Customers are instructed to: 1. Review your inventory to determine if you have any unused affected product within your facility. See Table above for affected Custom Pak. 2. Segregate any unused affected product from your inventory. 3. An Alcon associate will reach out to you directly to arrange for the return and replacement of your affected inventory of Alcon Custom Pak. 4. Fill out the attached Response Form , even if you have zero (0) units remaining in inventory and return the form to Alcon using the contact information provided on the form. 5. Please forward this information to: " all departments within your organization who may be in possession of this affected product; and " any other organization to which this product may have been transferred. For questions - contact Alcon Customer Service at 1-800-862-5266

Distribution

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

Quantity

320 kits