LENSX LASER SYSTEM
Received Jun 16, 2026
Report 2028159-2026-00866 · MDR key 25516786
Device
Generic name
Ophthalmic Femtosecond Laser
Manufacturer
Alcon Lensx, Inc.Model number
550Catalog number
8065998162
Lot number
NA
Product problems
- Failure to Align
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 PHYSICIAN REPORTED THAT CAPSULE AND LENS ARE NOT CENTERING AFTER PRESSING THE AUTO POSITIONING BUTTON IN UNKNOWN EYE OF THE PATIENT DURING REFRACTIVE SURGERY. SURGEON HAS TO MANUALLY ADJUST CENTRATION.