FDA Adverse Event
Injury
Summary report: N
ALLEGRETTO WAVE EYE-Q
MDR report key: 3771054
·
Received December 18, 2013
Report
- Report Number
- 3003288808-2013-00822
- 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
- MN, 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 TRACE DIFFUSE LAMELLAR KERATITIS (DLK) AT LASIK POST-OPERATIVE VISIT. ADDITIONAL INFORMATION INDICATED THE PT'S TOPICAL STEROID DROPS WERE INCREASED. THIS REPORT REFERENCES THE LEFT EYE. AN ADDITIONAL REPORT WILL BE FILED FOR THE RIGHT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 664080 | ALLEGRETTO WAVE EYE-Q | OPHTHALMIC EXCIMER LASER SYSTEM | LZS | WAVELIGHT GMBH | 8065990601 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Required Intervention | INTRALASE: |