MalfunctionOOE
WAVELIGHT FS200 FEMTOSECOND LASER
Received Mar 25, 2026
Report 3003288808-2026-00158 · MDR key 24685113
Device
Generic name
Ophthalmic Laser
Manufacturer
Wavelight GmbhModel number
NACatalog number
8065000123
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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
Description of Event or Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THIN FLAP WAS OBSERVED IN THE UNKNOWN EYE OF THE PATIENT DURING REFRACTIVE SURGERY.