Constellation Vision System, REF: 8065751150
FDA Recall Z-0099-2024 · Posted 2023-10-11
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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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