FDA Adverse Event
Injury
Summary report: N
ALLEGRETTO WAVE
MDR report key: 3093805
·
Received April 30, 2013
Report
- Report Number
- 3003288808-2013-00203
- Event Type
- Injury
- Date Received
- April 30, 2013
- Report Date
- April 1, 2013
- Manufacturer
- WAVELIGHT GMBH
- Product Code
- LZS
- PMA / PMN Number
- P030008/P02
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, 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 INFO BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
A SURGEON REPORTS THAT SEVERAL PTS WHO HAVE HAD LASIK ARE MEASURED POST-OPERATIVELY WITH A "90 DEGREE ROTATION OF THE INTENDED CYLINDRICAL COMPONENT'S ANGLE". THIS REPORT WILL ADDRESS THE RIGHT EYE OF THE FIRST PT (B)(4). ADDITIONAL INFO HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 186681 | ALLEGRETTO WAVE | OPHTHALMIC EXCIMER LASER SYSTEM | LZS | WAVELIGHT GMBH | 8065990600 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Other |