FDA Adverse Event
Malfunction
Summary report: N
PUREPOINT
MDR report key: 1220379
·
Received October 31, 2008
Report
- Report Number
- 2028159-2008-00396
- Event Type
- Malfunction
- Date Received
- October 31, 2008
- Report Date
- October 2, 2008
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CENTER
- Product Code
- HQF
- PMA / PMN Number
- K062624
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE LIO WAS RECEIVED FOR IN HOUSE TESTING. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. THIS REPORT WAS MAILED TO FDA ON: 10/31/2008.
Description of Event or Problem · 1
THE SURGEON REPORTED THERE WAS NO AIMING BEAM OR ILLUMINATION WHEN USING THE LIO. THE ENDOPHOTOCOAGULATION MODE WORKS FINE. THE SURGEON SWITCHED TO THE CRYOPEXY TO COMPLETE THE CASE. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUREPOINT | LASER, OPHTHALMIC | HQF | ALCON - IRVINE TECHNOLOGY CENTER | PUREPOINT | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |