FDA Adverse Event
Malfunction
Summary report: N
LADARVISION 4000
MDR report key: 1000683
·
Received February 15, 2008
Report
- Report Number
- 1061857-2008-00012
- Event Type
- Malfunction
- Date Received
- February 15, 2008
- Date of Event
- January 17, 2008
- Report Date
- January 17, 2008
- Manufacturer
- ALCON - ORLANDO TECHNOLOGY CENTER
- Product Code
- LZS
- PMA / PMN Number
- P970043
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. THIS REPORT MAILED IN TO FDA ON: 02/15/2008.
Description of Event or Problem · 1
A SYSTEM OPERATOR REPORTS, THE SYSTEM STOPPED TRACKING AT 85% INTO A PROCEDURE. AFTER SEVERAL ATTEMPTS, THEY WERE ABLE TO REACQUIRE AND COMPLETE THE SURGERY. FOLLOW-UP INFO FROM THE SITE INDICATES THIS PT WAS NOT HARMED/INJURED BY THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LADARVISION 4000 | OPHTHALMIC EXCIMER LASER SYSTEM | LZS | ALCON - ORLANDO TECHNOLOGY CENTER | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |