FDA Adverse Event
Injury
Summary report: N
ALLEGRETTO WAVE EYE-Q
MDR report key: 3771051
·
Received December 18, 2013
Report
- Report Number
- 3003288808-2013-00823
- Event Type
- Injury
- Date Received
- December 18, 2013
- Date of Event
- November 23, 2013
- Report Date
- November 23, 2013
- Manufacturer
- WAVELIGHT GMBH
- Product Code
- LZS
- PMA / PMN Number
- P030008
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, 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
AN OPTOMETRIST REPORTED PT WITH DRY EYE AT LASIK POST-OPERATIVE VISIT. THIS REPORT REFERENCES THE RIGHT EYE. AN ADDITIONAL REPORT WILL BE FILED FOR THE LEFT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 664079 | ALLEGRETTO WAVE EYE-Q | OPHTHALMIC EXCIMER LASER SYSTEM | LZS | WAVELIGHT GMBH | 8065990601 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Other | INTRALASE: |