Alcon Recalls LenSx Lasers Due to Incomplete Corneal Flap Creation
Alcon is voluntarily recalling 81 LenSx Laser Systems with Corneal Flap Capability due to reports of incomplete corneal flap creation during surgery.
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 medical device defect (incomplete corneal flap) that poses a risk of harm during surgery, but the source text does not report specific injuries or fatalities, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Alcon Research, Ltd. is conducting a voluntary recall of 81 LenSx Laser Systems equipped with Corneal Flap Capability. These devices are indicated for use in patients undergoing cataract surgery and refractive surgery. The recall affects units distributed in the United States and 20 other countries, including Albania, Australia, Brazil, and Germany.
The recall was initiated after Alcon received reports concerning incomplete corneal flap creation. This defect manifests as un-dissected areas within the side cut of the corneal flap. The source text does not specify the number of reported incidents or any resulting patient injuries.
Hospitals and clinics should identify affected units by checking the serial numbers listed in the official recall notice. Alcon is the recalling firm responsible for managing this safety action.
The recalled product
- Product
- LenSx Laser System. Indicated for use in patients undergoing cataract surgery and refractive surgery.
- Manufacturer
- Alcon Research, Ltd.
- Affected units
- 81
Distribution
Distribution scope not specified by the agency.
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