Recall Z-1328-2021— Alcon Research, LLC

Name: FDA recall Z-1328-2021
Creator: U.S. Food and Drug Administration
Published: 2021-02-02

Class II · Terminated

Class II FDA medical device recall by Alcon Research, LLC, initiated 2021-02-02, terminated 2023-06-30. It names one FDA 510(k) clearance: K880961. Product: Alcon Custom Ophthalmic Surgical Procedure Packs. Reason: Reports have been received concerning mold found on gowns included in custom ophthalmic surgery packages..

Recalling firm: Alcon Research, LLC
Classification: Class II
Status: Terminated
Initiated: 2021-02-02
Terminated: 2023-06-30
Firm location: Houston, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K880961 — ALCON SURGICAL PROCEDURE PACKSAlcon Laboratories·cleared 1988-04-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Alcon Custom Ophthalmic Surgical Procedure Packs

Reason for recall

Reports have been received concerning mold found on gowns included in custom ophthalmic surgery packages.

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