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Open, Classified

Constellation Vision System, REF: 8065751150

FDA Recall Z-0099-2024 · Posted 2023-10-11

Recalling FirmAlcon Research, LLC
Recall StatusOpen, Classified
Product CodeHQC
Date Initiated2023-08-18
Product Quantity3

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.

Firm Action

Starting on 8/18/23, Field Service Engineers told customers their devices needed pneumatics module replacements, and this replacement activity was subsequently completed. On 9/29/23, correction notices were mailed to customers informing them vision systems were corrected and asking they complete and return the response form to [email protected] Should you have any questions or concerns call Customer Service at 1-800-862-5266.

Root Cause

Component change control

Distribution Pattern

US: GA, IL, PR

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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