FDA Adverse Event
Malfunction
Summary report: N
OPHTHALAS 532 LASER
MDR report key: 419450
·
Received September 27, 2002
Report
- Report Number
- 2028159-2002-00266
- Event Type
- Malfunction
- Date Received
- September 27, 2002
- Date of Event
- August 29, 2002
- Report Date
- August 29, 2002
- Manufacturer
- ALCON - IRVINE TECHNOLOGY CENTER
- Product Code
- HQF
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
REPORTER NOTED THEY ASSEMBLED AND TEST CALIBRATED THE LASER. LASER WAS ON STANDBY, DR STARTED TO TREAT AND NOTICED FILTER WAS OFF. THERE WAS NO ERROR MESSAGE RECEIVED THAT THE FILTER WAS NOT IN PLACE. ADJUSTED THE TOGGLE, TRIED AGAIN, THEN FILTER WAS IN PLACE. NO PT OR USER INJURY OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OPHTHALAS 532 LASER | LASER PHOTOCOAGULATOR | HQF | ALCON - IRVINE TECHNOLOGY CENTER | 532 EYELITE | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |