LENSX LASER SYSTEM
Received Jul 7, 2026 · Event occurred Jun 10, 2026
Report 2028159-2026-00992 · MDR key 25729663
Device
Generic name
Ophthalmic Femtosecond Laser
Manufacturer
Alcon Research, Llc - Irvine Technology CenterModel number
550Catalog number
8065998162
Lot number
NA
Product problems
- Failure to Align
Patient
NA · Unknown
- Insufficient Information
Narrative
Description of Event or Problem
A NON HEALTHCARE PROFESSIONAL REPORTED THAT LENS FRAGMENTATION MARKS WERE VISIBLE WITHIN THE ANTERIOR CAPSULE, DESPITE THE ANTERIOR OFFSET BEING SET TO FIVE HUNDRED MICRONS IN THE UNKNOWN EYE OF THE PATIENT DURING REFRACTIVE SURGERY. THE PROCEDURE WAS COMPLETED AS PLANNED.
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).