Recall Z-0099-2024— Alcon Research, LLC

Name: FDA recall Z-0099-2024
Creator: U.S. Food and Drug Administration
Published: 2023-08-18

Class II · Ongoing

Class II FDA medical device recall by Alcon Research, LLC, initiated 2023-08-18. It names 2 FDA 510(k) clearances: K141065, K101285. Product: Constellation Vision System, REF: 8065751150. Reason: Ophthalmic microsurgical vision systems have a new Printed Circuit Board (PCB) design that could lead to higher voltage to a PCB component, that could cause component failure and loss of pressure control for the use of cutters, scissors, and forceps, which could lead to an increased risk of microbial infection, tissue damage and progressive visual impairment..

Recalling firm: Alcon Research, LLC
Classification: Class II
Status: Ongoing
Initiated: 2023-08-18
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

2 on FDA's record

K141065 — CONSTELLATION VISION SYSTEMAlcon Research, Ltd.·cleared 2014-08-22
K101285 — CONSTELLATION VISION SYSTEMAlcon Manufacturing, Ltd.·cleared 2010-11-12

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

Constellation Vision System, REF: 8065751150

Reason for recall

Ophthalmic microsurgical vision systems have a new Printed Circuit Board (PCB) design that could lead to higher voltage to a PCB component, that could cause component failure and loss of pressure control for the use of cutters, scissors, and forceps, which could lead to an increased risk of microbial infection, tissue damage and progressive visual impairment.

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