FDA Adverse Event
Malfunction
Summary report: N
OPHTHALAS 532 EYELITE LASER SYSTEM
MDR report key: 2043242
·
Received February 25, 2011
Report
- Report Number
- 2028159-2011-00180
- Event Type
- Malfunction
- Date Received
- February 25, 2011
- Report Date
- January 28, 2011
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CENTER
- Product Code
- GEX
- PMA / PMN Number
- K914334
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- 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 INFO BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
A SURGEON REPORTED THAT THE LASER WAS NOT WORKING NORMALLY AND THE POWER SETTING HAD TO BE INCREASED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM TO THE PT. ADDITIONAL INFO HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OPHTHALAS 532 EYELITE LASER SYSTEM | LASER INSTRUMENT, SURGICAL, POWERED | GEX | ALCON - IRVINE TECHNOLOGY CENTER | 8065500001 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |