Recall Z-2110-2025— Alcon Research LLC

Name: FDA recall Z-2110-2025
Creator: U.S. Food and Drug Administration
Published: 2025-04-28

Class II · Ongoing

Class II FDA medical device recall by Alcon Research LLC, initiated 2025-04-28. FDA's recall record names no specific 510(k) clearance for this event. Product: Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A. Reason: Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding. While the damage in the lidding is visibly noticeable, due to risk of sterility being compromised..

Recalling firm: Alcon Research LLC
Classification: Class II
Status: Ongoing
Initiated: 2025-04-28
Firm location: Fort Worth, TX, United States

Product description

Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A

Reason for recall

Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding. While the damage in the lidding is visibly noticeable, due to risk of sterility being compromised.

Data sourced from openFDA. This site is unofficial and independent of the FDA.