WAVELIGHT FS200 FEMTOSECOND LASER
Received Jul 7, 2026
Report 3003288808-2026-00292 · MDR key 25733387
Device
Generic name
Ophthalmic Laser
Manufacturer
Wavelight GmbhModel number
NACatalog number
8065000123
Lot number
NA
Product problems
- Unexpected Therapeutic Results
- Program or Algorithm Execution Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
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 CUSTOMER REPORTED DIFFICULTY REMOVING THE FLAP AND THE SYSTEM ERROR MESSAGE WAS DISPLAYED IN THE UNKNOWN EYE OF A PATIENT, DURING REFRACTIVE SURGERY. THE SURGERY WAS COMPLETED AND THE NO PATIENT INJURY OCCURRED. ADDITIONALLY, NO SURGERIES WERE INTERRUPTED OR POSTPONED DUE TO THE EVENT.