FDA Adverse Event
Injury
Summary report: N
LADAR6000 SYSTEM
MDR report key: 856099
·
Received May 24, 2007
Report
- Report Number
- 1061857-2007-00244
- Event Type
- Injury
- Date Received
- May 24, 2007
- Date of Event
- January 10, 2007
- Report Date
- April 24, 2007
- Manufacturer
- ALCON - ORLANDO TECHNOLOGY CENTER
- Product Code
- LZS
- PMA / PMN Number
- P970043
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION, INCLUDING ROOT CAUSE DETERMINATION IS IN PROGRESS.
Description of Event or Problem · 1
A SURGEON REPORTS AN 'ATYPICAL' RESULT FOLLOWING A BILATERAL CUSTOM MYOPIA PROCEDURE. IT IS UNKNOWN IF THERE WAS PATIENT IMPACT/INJURY ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. #1061857-2007-00243-RIGHT EYE. #1061857-2007-00244-LEFT EYE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LADAR6000 SYSTEM | OPHTHALMIC EXCIMER LASER SYSTEM | LZS | ALCON - ORLANDO TECHNOLOGY CENTER | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI YR | Other |