FDA Adverse Event
Injury
Summary report: N
WAVELIGHT EX500 EXCIMER LASER
MDR report key: 3121848
·
Received May 15, 2013
Report
- Report Number
- 3003288808-2013-00242
- Event Type
- Injury
- Date Received
- May 15, 2013
- Report Date
- April 19, 2013
- Manufacturer
- WAVELIGHT GMBH
- Product Code
- LZS
- PMA / PMN Number
- P030008
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- 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 SURGEON REPORTED THAT A PT WHO HAD UNDERGONE LASIK EXPERIENCED UNEXPECTED RESULTS. HE STATED THAT THE ABLATION PATTERN WAS NOT REGULAR, IRREGULAR ASTIGMATISM WAS INDUCED, AND THE QUALITY OF VISION IS WORSE. THIS FILE REFERENCES THE PT'S LEFT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 215000 | WAVELIGHT EX500 EXCIMER LASER | OPHTHALMIC EXCIMER LASER SYSTEM | LZS | WAVELIGHT GMBH | 8065990713 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Other |