FDA Adverse Event
Injury
Summary report: N
ALLEGRETTO WAVE EYE-Q
MDR report key: 4132815
·
Received September 29, 2014
Report
- Report Number
- 3003288808-2014-01452
- Event Type
- Injury
- Date Received
- September 29, 2014
- Date of Event
- August 21, 2014
- Report Date
- August 28, 2014
- Manufacturer
- WAVELIGHT GMBH
- Product Code
- LZS
- PMA / PMN Number
- P030008
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED. 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 ORTHOPTIST REPORTED SUSPECTED OVER CORRECTION FOLLOWING A LASIK PROCEDURE. THERE WAS AN ERROR MESSAGE REGARDING SECONDARY ENERGY OUT OF RANGE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT REFERENCES THE LEFT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 606418 | ALLEGRETTO WAVE EYE-Q | OPHTHALMIC EXCIMER LASER SYSTEM | LZS | WAVELIGHT GMBH | 8065990631 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |