FDA Adverse Event
Malfunction
Summary report: N
WAVELIGHT FS200 FEMTOSECOND LASER
MDR report key: 2160308
·
Received May 16, 2011
Report
- Report Number
- 3003288808-2011-00099
- Event Type
- Malfunction
- Date Received
- May 16, 2011
- Date of Event
- April 21, 2011
- Report Date
- April 21, 2011
- Manufacturer
- WAVELIGHT GMBH
- Product Code
- GEX
- PMA / PMN Number
- K101006
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- 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). THIS REPORT WAS MAILED TO FDA ON: (B)(4) 2011. (B)(4).
Description of Event or Problem · 1
CUSTOMER REPORTED AN INCOMPLETE FLAP DURING REFRACTIVE SURGERY. DURING F/U, THE SITE'S TECHNICIAN STATED THE SURGEON WAS NOT ABLE TO LIFT THE FLAP, THERE WAS NO PERFORATION AND THE PROCEDURE WAS ABORTED. THERE WAS NO PT HARM OR INJURY AND THE PT IS DOING 'VERY WELL'. THE PT WILL HAVE PRK IN THE FUTURE.
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 |