FDA Adverse Event
Injury
Summary report: N
LADARVISION 4000
MDR report key: 1061311
·
Received June 13, 2008
Report
- Report Number
- 1061857-2008-00107
- Event Type
- Injury
- Date Received
- June 13, 2008
- Date of Event
- March 13, 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
A SURGERY DATABASE PERFORMANCE VERIFICATION WAS CONDUCTED ON THIS SYSTEM AND THE ANALYSIS DETERMINED THE LASER PERFORMANCE FACTORS ANALYZED WERE OPERATING WITH SPECIFICATION DURING THE TIME OF THIS PATIENT'S SURGERY.
Description of Event or Problem · 1
A SURGEON REPORTS A PT THAT IS OVERCORRECTED FOLLOWING PRK REFRACTIVE SURGERY ON BOTH EYES. THIS REPORT IS FOR THE LEFT EYE, THE RIGHT EYE IS BEING REPORTED UNDER MFR REPORT #1061857-2008-00106. PATIENT RECORDS WERE REC'D AND INDICATE THE LEFT EYE WAS OVERCORRECTED BY +1.25 DIOPTER AND EXHIBITED A -.50 DIOPTER OF RESIDUAL ASTIGMATISM. THE LEFT EYE ALSO EXHIBITED A 1 LINE DECREASE IN BCVA. THE PT REPORTED A SHADOW UNDERNEATH EVERYTHING AND WHEN LOOKING AT STOPLIGHTS, SEES ANOTHER UNDERNEATH.
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 |