FDA Adverse Event
Injury
Summary report: N
HYDROVIEW INTRAOCULAR LENS
MDR report key: 317554
·
Received February 26, 2001
Report
- Report Number
- 6000107-2001-00066
- Event Type
- Injury
- Date Received
- February 26, 2001
- Date of Event
- February 19, 2001
- Report Date
- February 19, 2001
- Manufacturer
- BAUSCH & LOMB SURGICAL
- Product Code
- HQL
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
LENS OPACIFICATION WAS OBSERVED APPROX 30 MONTHS POSTOPERATIVE. PT'S VISUAL ACUITY IS 20/60 AT LAST EXAM. LENS REMAINS IMPLANTED IN THE PT'S EYE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 7691 | HYDROVIEW INTRAOCULAR LENS | INTRAOCULAR LENS | HQL | BAUSCH & LOMB SURGICAL | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Other |