FDA Adverse Event
Injury
Summary report: N
WAVELIGHT FS200 FEMTOSECOND LASER
MDR report key: 3093807
·
Received April 30, 2013
Report
- Report Number
- 3003288808-2013-00205
- Event Type
- Injury
- Date Received
- April 30, 2013
- Date of Event
- February 27, 2013
- Report Date
- April 2, 2013
- Manufacturer
- WAVELIGHT GMBH
- Product Code
- GEX
- PMA / PMN Number
- K101006
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- 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 HEALTH CARE PROFESSIONAL REPORTED DURING LASIK PROCEDURE A BROKEN PT INTERFACE INJURED PT'S CORNEA. ADDITIONAL INFO HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 186970 | WAVELIGHT FS200 FEMTOSECOND LASER | OPHTHALMIC FEMTOSECOND LASER | GEX | WAVELIGHT GMBH | FS200 | 00069 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |