LENSX LASER SYSTEM
Received Mar 11, 2026 · Event occurred Feb 18, 2026
Report 2028159-2026-00310 · MDR key 24566739
Device
Generic name
Ophthalmic Femtosecond Laser
Manufacturer
Alcon Research, Llc - Irvine Technology CenterModel number
550Catalog number
8065998162
Lot number
NA
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
NA · Unknown
- Insufficient Information
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION PROVIDED IN D.9., H.3., H.6., AND H.11. 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. THE COMPANY REPRESENTATIVE WAS UNABLE TO CONFIRM NOR REPLICATE THE REPORTED ISSUE. THE SYSTEM WAS TESTED AND FOUND TO MEET PRODUCT SPECIFICATIONS. THE SYSTEM WAS FOUND TO HAVE NO PROBLEM. THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT IS INCONCLUSIVE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
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 NURSE REPORTED THAT DURING THE CREATION OF FLAP, THE FLAP BECOMES SUPERFICIAL IN THE TEMPORAL REGION IN UNKNOWN EYE OF THE PATIENT DURING REFRACTIVE SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.