FDA Adverse Event
Injury
Summary report: N
LADARVISION 4000
MDR report key: 1061313
·
Received June 13, 2008
Report
- Report Number
- 1061857-2008-00104
- Event Type
- Injury
- Date Received
- June 13, 2008
- Date of Event
- February 8, 2008
- Report Date
- May 15, 2008
- 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
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. THIS REPORT MAILED TO FDA ON: 06/13/2008. .
Description of Event or Problem · 1
A SYSTEM OPERATOR REPORTS A PT WAS OVERCORRECTED FOLLOWING LASIK REFRACTIVE SURGERY ON BOTH EYES. THIS REPORT IS FOR THE RIGHT EYE, THE LEFT EYE IS BEING REPORTED UNDER MANUFACTURER REPORT # 1061857-2008-00105. PT RECORDS WERE RECEIVED AND INDICATED THE RIGHT EYE WAS OVERCORRECTED BY +1.00 DIOPTER AT 2 MONTHS POST-OP. THIS EYE ALSO EXPERIENCED A 1 LINE DECREASE IN BCVA, HOWEVER THE RECORDS ALSO INDICATE UCVA IN THE RIGHT EYE IMPROVED FROM 20/CF TO 20/15. ADDITIONAL INFO HAS BEEN REQUESTED.
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 | Other |