LENSX LASER SYSTEM
Received Jul 20, 2026 · Event occurred Jun 1, 2026
Report 2028159-2026-01095 · MDR key 25868314
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. ALCON LENSX (SITE #3008772169) IS NO LONGER OPERATIONAL. LENSX MANUFACTURED PRODUCTS ARE MAINTAINED AND INVESTIGATED BY THE ALCON RESEARCH, LTD. IRVINE TECHNOLOGY CENTER SITE #2028159). THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
Description of Event or Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE FLAP WAS DIFFICULT TO REMOVE RESULTED IN AN INCOMPLETE FLAP IN THE UNKNOWN EYE OF A PATIENT DURING REFRACTIVE SURGERY.