Constellation Vision System surgical units recalled for pressure control defect
Alcon Research recalls Constellation Vision System ophthalmic microsurgical units due to a printed circuit board design flaw that could disable pressure control, risking infection and tissue damage.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving a surgical system with potential for serious patient harm including tissue damage and infection. However, no illnesses or injuries have been reported; the hazard is theoretical based on the conditional language in the source ('could lead to'), placing it in the High category per the rubric.
Plain-English summary
Alcon Research, LLC is recalling the Constellation Vision System, REF: 8065751150, an ophthalmic microsurgical vision system used in eye surgeries. The recall affects three units that were distributed in the United States (Georgia, Illinois, and Puerto Rico). Serial numbers of the affected units are 1403028701X, 1202865201X, and 0802983301X.
The recall is due to a flaw in the printed circuit board (PCB) design. Under certain conditions, this design defect could cause higher voltage to reach a PCB component, leading to component failure. If the component fails, it could result in loss of pressure control for the system's cutting instruments, including cutters, scissors, and forceps.
Loss of pressure control during eye surgery could increase the risk of unintended tissue damage, microbial infection, and progressive visual impairment in patients. Ophthalmologists and surgical teams using this specific equipment may be affected.
Healthcare facilities with these serial numbers should contact Alcon Research, LLC immediately. Affected units should not be used for surgical procedures until the issue is resolved.
The recalled product
- Product
- Constellation Vision System, REF: 8065751150
- Manufacturer
- Alcon Research, LLC
- Affected units
- 3
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- UDI-DI: 00380657511501
- Serial Numbers: 1403028701X
- 1202865201X
- 0802983301X
Distribution
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