WAVELIGHT FS200 FEMTOSECOND LASER
Received Apr 17, 2026
Report 3003288808-2026-00212 · MDR key 24907865
Device
Generic name
Ophthalmic Laser
Manufacturer
Wavelight GmbhModel number
NACatalog number
8065000123
Lot number
NA
Product problems
- Unexpected Therapeutic Results
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 HEALTHCARE PROFESSIONAL REPORTED THAT THE VERTICAL GAS BREAKTHROUGH AND THE TREATMENT WAS CONVERTED TO PHOTOREFRACTIVE KERATOMETRY IN THE UNKNOWN EYE OF A PATIENT, DURING REFRACTIVE SURGERY. THERE ARE MULTIPLE RELATED REPORTS FOR THIS FACILITY. THIS REPORT ADDRESSES THE PATIENT TWO, UNKNOWN EYE AND OTHER MANUFACTURER REPORTS WILL BE FILED.