FDA Adverse Event
Malfunction
Summary report: N
ALLEGRETTO WAVE EYE-Q
MDR report key: 2092835
·
Received May 5, 2011
Report
- Report Number
- 3003288808-2011-00089
- Event Type
- Malfunction
- Date Received
- May 5, 2011
- Date of Event
- April 5, 2011
- Report Date
- April 6, 2011
- Manufacturer
- WAVELIGHT GMBH
- Product Code
- LZS
- PMA / PMN Number
- P030008/P02
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- 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
SURGEON REPORTED THAT A LOW ENERGY SYSTEM MESSAGE WAS RECEIVED DURING SURGERY, ON ONE LASIK CASE. THE CASE WAS REPORTED TO HAVE BEEN COMPLETED SUCCESSFULLY, AFTER A SIX MIN DELAY. NO PT HARM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALLEGRETTO WAVE EYE-Q | OPHTHALMIC EXCIMER LASER SYSTEM | LZS | WAVELIGHT GMBH | 8065990631 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |