LENSX LASER SYSTEM
Received Jun 2, 2026
Report 2028159-2026-00786 · MDR key 25357544
Device
Generic name
Ophthalmic Femtosecond Laser
Manufacturer
Alcon Lensx, Inc.Model number
550Catalog number
8065998162
Lot number
NA
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
37 YR · Male
- Corneal Perforation
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 TORE AT THE HINGE WHILE LIFTING THE FLAP WHICH CREATED A FREE-FLOATING FLAP IN AN UNKNOWN EYE OF THE PATIENT DURING REFRACTIVE SURGERY. IT WAS UNCONFIRMED WHETHER IT WAS DUE TO THE SURGEON TECHNIQUE OF LIFTING OR FLAP CREATION. THE SURGERY WAS COMPLETED WAS ON SAME DAY.