WAVELIGHT FS200 FEMTOSECOND LASER
Received Jul 22, 2026 · Event occurred Jul 8, 2026
Report 3003288808-2026-00308 · MDR key 25903707
Device
Generic name
Powered Laser Surgical Instrument
Manufacturer
Wavelight GmbhModel number
NACatalog number
8065990941
Lot number
NA
Product problems
- Unexpected Therapeutic Results
Patient
29 YR · Male
- 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 NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT HAD EXPERIENCED VERTICAL GAS BREAK THROUGH LATER SURGEON CONVERTED THE PROCEDURE TO PHOTO REFRACTIVE KERATECTOMY IN RIGHT EYE DURING REFRACTIVE SURGERY.