FDA Adverse Event
Injury
Summary report: N
WAVELIGHT FS200 FEMTOSECOND LASER
MDR report key: 4012882
·
Received July 21, 2014
Report
- Report Number
- 3003288808-2014-01122
- Event Type
- Injury
- Date Received
- July 21, 2014
- Date of Event
- June 16, 2014
- Report Date
- June 18, 2014
- Manufacturer
- WAVELIGHT GMBH
- Product Code
- LZS
- PMA / PMN Number
- K101006
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, 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 ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
A TECHNICIAN REPORTED UNABLE TO FLAP LIFT DURING THE PROCEDURE. CASE WAS ABORTED. PATIENT IS FINE. PATIENT IS GOING TO RESCHEDULE FOR THIS FALL TO COMPLETE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 425592 | WAVELIGHT FS200 FEMTOSECOND LASER | OPHTHALMIC FEMTOSECOND LASER | LZS | WAVELIGHT GMBH | FS200 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |