LENSX LASER SYSTEM
Received May 27, 2026 · Event occurred Apr 30, 2026
Report 2028159-2026-00760 · MDR key 25297050
Device
Generic name
Ophthalmic Femtosecond Laser
Manufacturer
Alcon Lensx, Inc.Model number
550Catalog number
8065998162
Lot number
NA
Product problems
- Failure to Cut
- Suction Failure
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 DURING THE PROCEDURE THE CORNEAL FLAP WAS FAILED DUE TO SYSTEM WAS UNABLE TO ACHIEVE OR ADEQUATE THE SUCTION, RESULTED IN AN INCOMPLETE FLAP IN UNKNOWN EYE OF THE PATIENT DURING REFRACTIVE SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY.