Recall Z-0260-2024— Alcon Research, LLC

Name: FDA recall Z-0260-2024
Creator: U.S. Food and Drug Administration
Published: 2023-09-07

Class II · Ongoing

Class II FDA medical device recall by Alcon Research, LLC, initiated 2023-09-07. It names one FDA 510(k) clearance: K880961. Product: Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N VIRGINIA EYE SURG CTR. Reason: Custom surgical procedure packs contain latex gloves but are labeled as "latex free"..

Recalling firm: Alcon Research, LLC
Classification: Class II
Status: Ongoing
Initiated: 2023-09-07
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-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N VIRGINIA EYE SURG CTR

Reason for recall

Custom surgical procedure packs contain latex gloves but are labeled as "latex free".

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