FDA Adverse Event
Malfunction
Summary report: N
WAVELIGHT FS200 FEMTOSECOND LASER
MDR report key: 2160895
·
Received June 16, 2011
Report
- Report Number
- 3003288808-2011-00111
- Event Type
- Malfunction
- Date Received
- June 16, 2011
- Date of Event
- October 11, 2010
- Report Date
- October 11, 2010
- Manufacturer
- WAVELIGHT GMBH
- Product Code
- GEX
- PMA / PMN Number
- K101006
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVENT EVALUATION SHOWED BLIND VACUUM WAS CREATED AS SCLERA TISSUE COVERED THE SUCTION HOLE. EYE APPLANATION WAS MAINTAINED THROUGH THE PRESSURE OF THE APPLANATION CONE, AND THE TREATMENT WAS ABLE TO CONTINUE. CUSTOMER WAS ADVISED TO WORK IN A DRYER CONDITION TO KEEP SUCTION HOLE FREE. ROOT CAUSE WAS ASSESSED TO BE RELATED TO OPERATIONAL CONTEXT; SPECIFICALLY SUCTION HOLE BEING COVERED BY SCLERAL TISSUE. (B)(4). THIS REPORT WAS MAILED TO FDA ON: (B)(4) 2011. (B)(4).
Description of Event or Problem · 1
SURGEON REPORTS VACUUM LOSS AT THE EYE. DEVICE CONTINUES LASERING. NO PATIENT HARM REPORTED AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.
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 |