FDA Adverse Event
Injury
Summary report: N
OPHTHALAS 532 EYELITE
MDR report key: 502972
·
Received December 24, 2003
Report
- Report Number
- 2028159-2003-00243
- Event Type
- Injury
- Date Received
- December 24, 2003
- Report Date
- November 24, 2003
- Manufacturer
- ALCON-IRVINE TECHNOLOGY CENTER
- Product Code
- HQB
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REPORTER NOTED STARTING POWER AT 0.2 AND TITRATING POWER UP TO 1.6 TO OBTAIN ADEQUATE PHOTOCOAGULATION. SUDDENLY RECEIVED FULL POWER, CAUSING HOLE IN RETINA. DID AN UNPLANNED CRYOPEXY TO REPAIR RETINAL DETACHMENT AND HOLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OPHTHALAS 532 EYELITE | LASER PHOTOCOAGULATOR | HQB | ALCON-IRVINE TECHNOLOGY CENTER | 532 EYELITE | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Required Intervention |