FDA Adverse Event
Malfunction
Summary report: N
CEEON UV-ABSORBING SILICONE LENS
MDR report key: 116321
·
Received August 26, 1997
Report
- Report Number
- 2083358-1997-00009
- Event Type
- Malfunction
- Date Received
- August 26, 1997
- Report Date
- July 24, 1997
- Manufacturer
- PHARMACIA IOVISION, INC.
- Product Code
- HQL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PT HAD A CATARACT EXTRACTION 26/MAY95 WITH IMPLANT OF MODEL 127 (920). POLYCHROME MARKING OF THE OPTIC IOL BY THE OXYDATED JAWS OF THE FOLDING FORCEPS OCCURRED DURING IMPLANT. SUBSEQUENTLY, THE PT DEVELOPED KERATIC PRECIPITATES (KPS) AND UVEITIS (TYNDALL EFFECT IN THE ANTERIOR CHAMBER). EXPLANT OF THE LENS WAS DONE ON 6JUL95 AND REIMPLANTATION OF A PMMA IOL. OUTCOME WAS CONJUNCTIVAL AND LIMBIC HYPEREMIA AND KPS FOR TWO MONTHS. NO FURTHER INFO IS EXPECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CEEON UV-ABSORBING SILICONE LENS Implant | INTRAOCULAR LENS | HQL | PHARMACIA IOVISION, INC. | 127 (920) | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Required Intervention | BSS| VISCOAT| MAXIDROL AND STERDEX (POST OPERATIVE TREATMENT) |