WAVELIGHT FS200 FEMTOSECOND LASER
Received Apr 20, 2026 · Event occurred Mar 20, 2026
Report 3003288808-2026-00219 · MDR key 24925856
Device
Generic name
Ophthalmic Laser
Manufacturer
Wavelight GmbhModel number
NACatalog number
8065000123
Lot number
NA
Product problems
- Unexpected Therapeutic Results
Patient
51 YR · Female
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Description of Event or Problem
A HEALTHCARE PROFESSIONAL REPORTED THAT THE VERTICAL GAS BREAK THROUGH IN LEFT EYE OF THE PATIENT DURING REFRACTIVE SURGERY. SURGEON DID NOT LIFT THE FLAP ON THE SAME DAY INSTEAD HE CONVERTED THE PATIENT TO PHOTOREFRACTIVE KERATECTOMY.
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).