Constellation Vision System, REF: 8065751150
Reported: October 18, 2023 Initiated: August 18, 2023 #Z-0099-2024
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.
Details
- Recalling Firm
- Alcon Research, LLC
- Units Affected
- 3
- Distribution
- US: GA, IL, PR
- Location
- Irvine, CA
Frequently Asked Questions
What product was recalled? ▼
Constellation Vision System, REF: 8065751150. Recalled by Alcon Research, LLC. Units affected: 3.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 18, 2023. Severity: Moderate. Recall number: Z-0099-2024.
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