LENSX LASER SYSTEM
Received Feb 27, 2026
Report 2028159-2026-00252 · MDR key 24469757
Device
Generic name
Ophthalmic Femtosecond Laser
Manufacturer
Alcon Lensx, Inc.Model number
550Catalog number
8065998162
Lot number
NA
Product problems
- Failure to Cut
Patient
NA · Unknown
- Insufficient Information
Narrative
Additional Manufacturer Narrative
H.3., H.6.: INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
Description of Event or Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FLAP RESISTANCE IN THE UNKNOWN EYE DURING REFRACTIVE SURGERY.
Additional Manufacturer Narrative
A MANUFACTURING DEVICE HISTORY RECORD REVIEW WAS PERFORMED PRIOR TO PRODUCT RELEASE TO ENSURE THAT THE PRODUCT WAS MANUFACTURED IN COMPLIANCE WITH THE DEVICE MASTER RECORD. BASED ON THE ASSESSMENT, THE PRODUCT MET RELEASE CRITERIA. THE COMPANY REPRESENTATIVE WAS ABLE TO CONFIRM THE REPORTED ISSUE. THE NONCONFORMING CYSTAL COMPONENT WAS REPLACED TO ADDRESS THE ISSUE. THE SYSTEM WAS TESTED AND FOUND TO MEET PRODUCT SPECIFICATIONS. THE COMPLAINT WAS FOUND TO HAVE MET SPECIFICATION. THE ROOT CAUSE OF THE REPORTED EVENT IS ATTRIBUTED TO A NONCONFORMING CYSTAL COMPONENT. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).