FDA Adverse Event
Other
Summary report: N
ALLEGRETTO WAVE EYE-Q
MDR report key: 2163660
·
Received June 10, 2011
Report
- Report Number
- 3003288808-2011-00125
- Event Type
- Other
- Date Received
- June 10, 2011
- Date of Event
- May 13, 2011
- Report Date
- May 13, 2011
- Manufacturer
- WAVELIGHT GMBH
- Product Code
- LZS
- PMA / PMN Number
- P030008
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, 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 INFO BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
A LASER TECH REPORTS ONE EYE WAS INADVERTENTLY TREATED AT VERTEX DISTANCE OF ZERO DUE TO USER ERROR. THE SURGEON FAILED TO RESET THE PROPER VERTEX DISTANCE. PT'S OUTCOME IS UNKNOWN; HOWEVER, THE SURGEON STATED HE IS NOT CONCERNED ABOUT THE PT'S OUTCOME. ADDITIONAL INFO HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALLEGRETTO WAVE EYE-Q | OPHTHALMIC EXCIMER LASER SYSTEM | LZS | WAVELIGHT GMBH | 8065990601 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |