Recall Z-0939-2026— Alcon Research LLC
Class I · Ongoing
Class I FDA medical device recall by Alcon Research LLC, initiated 2025-11-24. 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 Numbers: 9903-20, 17188-04, 19762-03, 19203-04, 19203-04, 17957-10 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: Ophthalmic procedure packs may have incomplete seals affecting sterility..
- Recalling firm
- Alcon Research LLC
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2025-11-24
- Firm location
- Fort Worth, TX, United States
Product description
Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 19203-04, 19203-04, 17957-10 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
Ophthalmic procedure packs may have incomplete seals affecting sterility.
Data sourced from openFDA. This site is unofficial and independent of the FDA.