Alcon LenSx Ophthalmic Laser Recalled for Gantry Motion Defect
Alcon LenSx is recalling 75 ophthalmic lasers used in cataract surgery due to reports of unexpected downward motion of the gantry.
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: The recall involves a high-risk medical device where a mechanical defect (gantry motion) poses a risk of harm during surgery, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Alcon LenSx, Inc. is recalling 75 units of the Alcon LenSx Ophthalmic Laser. This device is used in cataract surgery for the creation of corneal cuts, anterior capsulotomy, and laser phacofragmentation.
The recall was initiated after the company received reports of unexpected downward motion of the gantry. The affected units were distributed worldwide.
Healthcare providers should check their serial numbers against the list provided in the official recall notice to determine if their equipment is affected. Consumers are not directly affected as this is a professional medical device.
The recalled product
- Product
- Alcon LenSx Ophthalmic Laser, for use in cataract surgery for the creation of corneal cuts/incisions, anterior capsulotomy and laser phacofragmentation.
- Manufacturer
- Alcon LenSx, Inc.
- Affected units
- 75
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 (20)
- (US) Serial Numbers: 0311-A007
- 0511-A013
- 0611-A017
- 0611-A018
- 0711-A021
- 0811-A026
- 0811-A027
- 0811-A033
- 0811-A035
- 0911-A039
- 0911-A045
- 1011-A050
- 1011-A062
- 1111-A067
- 1111-A073
- 1111-A077
- 1111-A080
- 1111-A085
- 1211-A086
- 1211-A087
Distribution
Distribution scope not specified by the agency.
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