WAVELIGHT FS200 FEMTOSECOND LASER
Report
- Report Number
- 3003288808-2023-00128
- Event Type
- Injury
- Date Received
- May 12, 2023
- Date of Event
- April 21, 2023
- Report Date
- August 8, 2023
- Manufacturer
- WAVELIGHT GMBH
- Product Code
- GEX
- PMA / PMN Number
- K101006
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- 003
Narratives
A REVIEW OF THE DEVICE HISTORY RECORD TRACEABLE TO THE REPORTED SERIAL NUMBER INDICATES THAT THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTANCE CRITERIA. A REVIEW OF THE TECHNICAL SERVICE ONSITE SHOWED NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THIS EVENT: LASER WAS SUCCESSFULLY VERIFIED PRIOR TO AND AFTER THE DAY OF THE TREATMENT. NO SAMPLE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE ROOT CAUSE IS USER HANDLING. THE CUSTOMER MISTAKENLY MADE A NASAL/180 INCISION INSTEAD OF TEMPORAL/0 OS. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
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).
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT AN INCORRECT ORIENTATION OF THE INCISION FLAP WAS CREATED AND USED NASAL INCISION INSTEAD OF TEMPORAL IN THE LEFT EYE OF A PATIENT DURING LASER APPLICATION (LASIK SURGERY). ADDITIONAL INFORMATION HAS BEEN REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1661579 | WAVELIGHT FS200 FEMTOSECOND LASER | POWERED LASER SURGICAL INSTRUMENT | GEX | WAVELIGHT GMBH | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Male | Required Intervention |