FDA Adverse Event
Injury
Summary report: N
LADARVISION
MDR report key: 1081152
·
Received June 19, 2008
Report
- Report Number
- 1061857-2008-00119
- Event Type
- Injury
- Date Received
- June 19, 2008
- Date of Event
- January 18, 2002
- Report Date
- May 20, 2008
- Manufacturer
- ALCON - ORLANDO TECHNOLOGY CTR
- Product Code
- LZS
- PMA / PMN Number
- P970043
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE.
Description of Event or Problem · 1
RECEIVED A VOLUNTARY MEDWATCH THAT WAS SUBMITTED BY A PT. THE PT STATES 6 YRS FOLLOWING REFRACTIVE SURGERY, THE PT'S VISION IS FUNCTIONAL, BUT FLUCTUATES AND STILL HAS VISUAL DISTURBANCES. THE PT STATED THE DAMAGE IS PERMANENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LADARVISION | OPHTHALMIC EXCIMER LASER SYSTEM | LZS | ALCON - ORLANDO TECHNOLOGY CTR | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |