LENSX LASER SYSTEM
Received Jul 6, 2026 · Event occurred Jun 19, 2026
Report 2028159-2026-00989 · MDR key 25719941
Device
Generic name
Ophthalmic Femtosecond Laser
Manufacturer
Alcon Research, Llc - Irvine Technology CenterModel number
550Catalog number
8065998162
Lot number
NA
Product problems
- Failure to Cut
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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
Description of Event or Problem
A PHYSICIAN REPORTED THAT PORTION OF THE FLAP SIDE CUT WAS INCOMPLETE IN UNKNOWN EYE DURING REFRACTIVE SURGERY, THE INCOMPLETE SEGMENT WAS MANUALLY DISSECTED WITH A BLADE BY THE SURGEON. THE SURGERY WAS COMPLETED WITHOUT ANY FURTHER ISSUES