FDA Adverse Event
Malfunction
Summary report: N
ALLEGRETTO WAVE EYE-Q
MDR report key: 1940117
·
Received December 22, 2010
Report
- Report Number
- 3003288808-2010-00512
- Event Type
- Malfunction
- Date Received
- December 22, 2010
- Date of Event
- December 9, 2010
- Report Date
- December 9, 2010
- Manufacturer
- WAVELIGHT GMBH
- Product Code
- LZS
- PMA / PMN Number
- P030008
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, 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 ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
SURGEON REPORTED FIXATION LIGHT WAS NOT VISIBLE. UPON FURTHER COMMUNICATION WITH SURGEON, IT WAS LEARNED THAT SURGERIES HAD NOT YET COMMENCED, WHEN IT WAS NOTICED THAT THE FIXATION LIGHT WAS NOT PRESENT. CASES WERE STATED TO HAVE BEEN DELAYED FOR 2 HOURS, WITHOUT IMPACT, AFTER WHICH TIME FIELD ENGINEER ARRIVED AT SITE TO RESOLVE THE REPORTED ISSUE.
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 |