FDA Adverse Event
Malfunction
Summary report: N
ALLEGRETTO WAVE EYE-Q
MDR report key: 2161061
·
Received June 16, 2011
Report
- Report Number
- 3003288808-2011-00131
- Event Type
- Malfunction
- Date Received
- June 16, 2011
- Date of Event
- May 25, 2010
- Report Date
- May 25, 2010
- Manufacturer
- WAVELIGHT GMBH
- Product Code
- LZS
- PMA / PMN Number
- P030008/P02
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EG
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
DURING THE ONSITE INVESTIGATION, THE MONITOR WAS REPLACED. NO SPECIFIC ROOT CAUSE WAS IDENTIFIED. (B)(4).
Description of Event or Problem · 1
CUSTOMER REPORTS THE EYE TRACKER MONITOR DOES NOT DETECT A VIDEO SIGNAL. NO PT HARM REPORTED AND NO FURTHER INFO WAS PROVIDED.
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 |