FDA Adverse Event
Malfunction
Summary report: N
ALLEGRETTO WAVE EYE-Q
MDR report key: 1854314
·
Received September 30, 2010
Report
- Report Number
- 3003288808-2010-00439
- Event Type
- Malfunction
- Date Received
- September 30, 2010
- Date of Event
- September 3, 2010
- Report Date
- September 3, 2010
- Manufacturer
- WAVELIGHT GMBH
- Product Code
- LZS
- PMA / PMN Number
- P030008
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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 INFORMATION BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
A TECHNICIAN REPORTS THAT DURING REFRACTIVE SURGERY, THE PT WAS NOT ABLE TO SEE THE FIXATION LIGHT. THE PROCEDURE ON BOTH EYES WAS COMPLETED THAT DAY. AT ONE DAY POST-OP, UCVA ON BOTH RIGHT AND LEFT EYE OF THIS PT WAS 20/20. THE SURGEON HAS NO CONCERNS FOR THIS PT'S OUTCOME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALLEGRETTO WAVE EYE-Q | OPHTHALMIC EXCIMER LASER SYSTEM | LZS | WAVELIGHT GMBH | 8065990601 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR |