Alcon Research LLC: Device Recall

Recall Details

Recall Number

Z-0939-2026

Classification

Class I

Product Type

Device

Recalling Firm

Alcon Research LLC

Status

Ongoing

Date Initiated

11/24/2025

Location

Fort Worth, TX, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

151 units

Reason for Recall

Ophthalmic procedure packs may have incomplete seals affecting sterility.

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

Distribution Pattern

US Nationwide distribution in the states of CA, ND, UT.

Other Recalls by Alcon Research LLC

• Class II: Risk 09/30/2025
  Potential for a weak seal in some units resulting in compromise in sterility.
• Class II: Risk 09/15/2025
  XXX
• Class II: Risk 08/05/2025
  Due to incomplete seals in the pouch which provide the sterile barrier.
• Class II: Risk 08/05/2025
  Due to incomplete seals in the pouch which provide the sterile barrier.
• Class II: Risk 08/05/2025
  Due to incomplete seals in the pouch which provide the sterile barrier.

View all recalls by Alcon Research LLC →