FDA Adverse Event
Injury
Summary report: N
KELMAN TYPE II ANTERIOR CHAMBER LENS
MDR report key: 376418
·
Received February 8, 2002
Report
- Report Number
- 2023366-2002-00001
- Event Type
- Injury
- Date Received
- February 8, 2002
- Report Date
- January 16, 2002
- Manufacturer
- BAUSCH & LOMB
- Product Code
- HQL
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
LENS WAS EXPLANTED DUE TO PATIENT DEVELOPING "PBK". A CORNEAL TRANSPLANT AND VITRECTOMY WERE PERFORMED. SURGEON FEELS INCIDENT IS PRODUCT RELATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KELMAN TYPE II ANTERIOR CHAMBER LENS | INTRAOCULAR LENS | HQL | BAUSCH & LOMB | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Required Intervention |