FDA Medical Device Recalls (openFDA)
Alcon Research, LLC: Constellation Vision System, REF: 8065751150
- Recall number
- Z-0099-2024
- Recalling firm
- Alcon Research, LLC
- Product
- Constellation Vision System, REF: 8065751150
- Status
- Open, Classified
- Initiated
- 2023-08-18
- Posted
- 2023-10-11
- Terminated
- not on file
- 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.
- Root cause
- Component change control
- 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 Market.Actions@Alcon.com Should you have any questions or concerns call Customer Service at 1-800-862-5266.
- Quantity
- 3
- Distribution
- US: GA, IL, PR
- Lot, serial or model codes
- UDI-DI: 00380657511501, Serial Numbers: 1403028701X, 1202865201X, 0802983301X
- 510(k) numbers
- ["K101285","K141065"]
- PMA numbers
- not on file
- Product code
- HQC
- Firm FEI
- 1000125771
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28