FDA Adverse Event
Malfunction
Summary report: N
WAVELIGHT FS200 FEMTOSECOND LASER
MDR report key: 2160331
·
Received May 16, 2011
Report
- Report Number
- 3003288808-2011-00100
- Event Type
- Malfunction
- Date Received
- May 16, 2011
- Date of Event
- April 23, 2011
- Report Date
- April 23, 2011
- Manufacturer
- WAVELIGHT GMBH
- Product Code
- GEX
- PMA / PMN Number
- K101006
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L INFO BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
A SURGEON REPORTS A SCANNING ERROR MESSAGE DURING REFRACTIVE SURGERY AT 80% COMPLETION. SYSTEM SHUT DOWN, AND WAS REBOOTED. TREATMENT WAS REPROGRAMMED AND COMPLETED. NO PT HARM OR INJURY HAS BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WAVELIGHT FS200 FEMTOSECOND LASER | OPHTHALMIC FEMTOSECOND LASER | GEX | WAVELIGHT GMBH | FS200 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |