FDA Adverse Event
Malfunction
Summary report: N
OPHTHALAS 532 EYELITE LASER SYSTEM
MDR report key: 2172621
·
Received June 24, 2011
Report
- Report Number
- 2028159-2011-00727
- Event Type
- Malfunction
- Date Received
- June 24, 2011
- Date of Event
- May 25, 2011
- Report Date
- May 26, 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
BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
A BIOMEDICAL TECH REPORTED THAT THE SYS TURNED ON, BUT WOULD NOT INITIALIZE. A PT HAD BEEN GIVEN GENERAL ANESTHESIA IN PREPARATION FOR SURGERY, BUT THE SURGERY WAS CANCELLED. NO HARM TO THE PT WAS REPORTED.
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 | UNK |