LENSX LASER SYSTEM
Received Jun 2, 2026 · Event occurred Apr 27, 2026
Report 2028159-2026-00787 · MDR key 25358649
Device
Generic name
Ophthalmic Femtosecond Laser
Manufacturer
Alcon Lensx, Inc.Model number
550Catalog number
8065998162
Lot number
NA
Product problems
- Unexpected Therapeutic Results
Patient
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 WITH THE CAPSULOTOMY TAGS IN UNKNOWN EYE OF THE PATIENT DURING REFRACTIVE SURGERY. INTERVENTION ISSUE HAS BEEN RESOLVED, THE SURGERY COMPLETED ON SAME DAY.