FDA Adverse Event
Injury
Summary report: N
LADARVISION 4000
MDR report key: 1000921
·
Received February 20, 2008
Report
- Report Number
- 1061857-2008-00020
- Event Type
- Injury
- Date Received
- February 20, 2008
- Date of Event
- November 9, 2007
- Report Date
- November 19, 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
- SP
- 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 INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
A SURGEON REPORTED A PATIENT WITH DIFFUSE LAMELLAR KERATITIS (DLK) FOLLOWING REFRACTIVE SURGERY AND WAS TREATED WITH TOPICAL CORTICOSTEROIDS. ADDITIONAL INFORMATION PROVIDED INDICATES THE OUTCOME OF THE EVENT AND THE PROGNOSIS OF THE PATIENT ARE UNKNOWN AT THIS TIME. ADDITIONAL CHECKUPS BY THE OPHTHALMOLOGIST WERE REQUIRED.
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 | 37 YR | Required Intervention |