FDA Adverse Event
Malfunction
Summary report: N
ALLEGRETTO WAVE EYE-Q
MDR report key: 3061156
·
Received April 10, 2013
Report
- Report Number
- 3003288808-2013-00164
- Event Type
- Malfunction
- Date Received
- April 10, 2013
- Date of Event
- March 14, 2013
- Report Date
- March 14, 2013
- Manufacturer
- WAVELIGHT GMBH
- Product Code
- LZS
- PMA / PMN Number
- P030008
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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 CENTER DIRECTOR REPORTED THAT THE PRESCRIPTION -6.00D WAS SEEN ON THE LASER DISPLAY, BUT THE PRINTOUT FOR THE TREATMENT DISPLAYED -5.00D. ADDITIONAL INFORMATION WAS REQUESTED ON MULTIPLE OCCASIONS BY PHONE, E-MAIL, AND LETTER, HOWEVER NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 152998 | ALLEGRETTO WAVE EYE-Q | OPHTHALMIC EXCIMER LASER SYSTEM | LZS | WAVELIGHT GMBH | 8065990631 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |