LENSX LASER SYSTEM
Received Jul 6, 2026 · Event occurred Jun 10, 2026
Report 2028159-2026-00988 · MDR key 25719678
Device
Generic name
Ophthalmic Femtosecond Laser
Manufacturer
Alcon Lensx, Inc.Model number
550Catalog number
8065998162
Lot number
NA
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
NA · Unknown
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
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 SYSTEM RECEIVED A Z SERVO POSITION ERROR IN UNKNOWN EYE OF THE PATIENT DURING REFRACTIVE SURGERY AT THE END WHILE SYSTEM MAKING THE LAST SECONDARY INCISION. SURGERY WAS COMPLETED WITH MANUAL INCISION BY USING BLADE.