FDA Adverse Event
Malfunction
Summary report: N
WAVELIGHT FS200 FEMTOSECOND LASER
MDR report key: 2101968
·
Received May 18, 2011
Report
- Report Number
- 3003288808-2011-00097
- Event Type
- Malfunction
- Date Received
- May 18, 2011
- Date of Event
- April 14, 2011
- Report Date
- April 19, 2011
- Manufacturer
- WAVELIGHT GMBH
- Product Code
- LZS
- 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 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
CUSTOMER REPORTED IRREGULAR FLAP WAS CREATED DURING REFRACTIVE SURGERY. FOLLOW-UP INFORMATION FROM THE LASER TECHNICIAN INDICATED IT APPEARED LIKE THE GAS PROTRUDED MAKING A BUTTON HOLE. THE SURGEON WAS ABLE TO LIFT THE FLAP, SMOOTH IT OUT AND COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WAVELIGHT FS200 FEMTOSECOND LASER | OPHTHALMIC FEMTOSECOND LASER | LZS | WAVELIGHT GMBH | FS200 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR |