LENSX LASER SYSTEM
Received Apr 11, 2026 · Event occurred Feb 21, 2026
Report 2028159-2026-00482 · MDR key 24850112
Device
Generic name
Ophthalmic Femtosecond Laser
Manufacturer
Alcon Research, Llc - Irvine Technology CenterModel number
550Catalog number
8065998162
Lot number
ASKU
Product problems
- Failure to Cut
Patient
18 YR · Male
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Description of Event or Problem
A REPORT WAS RECEIVED FROM THE CHINESE HEALTH AUTHORITY. A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, DUE TO AN UNEVEN SURFACE OF THE PATIENT¿S EYEBALL, INCOMPLETE FLAP CREATION OCCURRED DURING REFRACTIVE SURGERY IN THE UNKNOWN EYE OF THE PATIENT. ADDITIONAL INSTRUMENTS WERE REQUIRED TO COMPLETE THE FLAP SEPARATION, WHICH RESULTED IN A DELAY OF THE SURGICAL PROCEDURE.
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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).