FDA Adverse Event
Malfunction
Summary report: N
WAVELIGHT FS200 FEMTOSECOND LASER
MDR report key: 4662395
·
Received April 6, 2015
Report
- Report Number
- 3003288808-2015-05159
- Event Type
- Malfunction
- Date Received
- April 6, 2015
- Date of Event
- November 6, 2014
- Report Date
- October 20, 2017
- Manufacturer
- WAVELIGHT GMBH
- Product Code
- OOE
- PMA / PMN Number
- K101006
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED. 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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
Additional Manufacturer Narrative · 1
PER DATABASE SEARCH, IT WAS FOUND THAT THIS REPORT IS A DUPLICATION, THE EVENT HAD BEEN PREVIOUSLY REPORTED UNDER MFR # 3003288808-2014-01732 (INTERNAL REF NUMBER (B)(4)). THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
A SURGEON REPORTED THAT THE FLAP THICKNESS IS THINNER THAN EXPECTED, OBSERVED DURING FLAP CREATION FO A LASIK PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 224839 | WAVELIGHT FS200 FEMTOSECOND LASER | OPHTHALMIC FEMTOSECOND LASER | OOE | WAVELIGHT GMBH | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR | Other |