FDA Adverse Event
Injury
Summary report: N
WAVELIGHT FS200 FEMTOSECOND LASER
MDR report key: 2980614
·
Received February 21, 2013
Report
- Report Number
- 3003288808-2013-00078
- Event Type
- Injury
- Date Received
- February 21, 2013
- Report Date
- January 24, 2013
- Manufacturer
- WAVELIGHT GMBH
- Product Code
- GEX
- PMA / PMN Number
- K101006
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RS
- 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 INFO BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
A HOSPITAL ENGINEER REPORTED THAT DURING THE FORMING OF A GRAFT, RED AIMER SHOWED TO BE ON THE LEFT FROM GREEN MARK, BUT BURNING WAS ON THE RIGHT. FOLLOW UP INFO FROM COMPANY SVC ENGINEER NOTED THAT THE EVENT WAS RELATED TO 'ERROR OF USE; THE MICROSCOPE WITH SYS OF VIDEOMONITORING IS DISPLAYED PHYSICALLY'. ADD'L INFO HAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 75136 | WAVELIGHT FS200 FEMTOSECOND LASER | OPHTHALMIC FEMTOSECOND LASER | GEX | WAVELIGHT GMBH | FS200 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |