FDA Adverse Event
Injury
Summary report: N
CHIROFLEX UV-ABSORBING SILICONE LENS
MDR report key: 218263
·
Received April 7, 1999
Report
- Report Number
- 2027189-1999-00007
- Event Type
- Injury
- Date Received
- April 7, 1999
- Date of Event
- March 8, 1999
- Report Date
- March 8, 1999
- Manufacturer
- CHIRON VISION CORP.
- Product Code
- HQL
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
THE LENS WAS REPLACED DUE TO A DISPLACED (DECENTERED) LENS. THE PATIENT PROGNOSIS IS GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CHIROFLEX UV-ABSORBING SILICONE LENS Implant | INTRA OCULAR LENS | HQL | CHIRON VISION CORP. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention |