FDA Adverse Event
Malfunction
Summary report: N
ISYMM ASPHERIC INTRAOCULAR LENS
MDR report key: 2181307
·
Received July 8, 2011
Report
- Report Number
- 3006723646-2011-00154
- Event Type
- Malfunction
- Date Received
- July 8, 2011
- Date of Event
- June 8, 2011
- Report Date
- July 8, 2011
- Manufacturer
- HOYA SURGICAL OPTICS, INC.
- Product Code
- HQL
- PMA / PMN Number
- P080004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
LENS WAS EXPLANTED BECAUSE THE CAPSULAR BAG TORE DURING SURGERY. IT WAS REPORTED THAT THE PT'S CAPSULAR BAG WAS FRAGILE. PT PROGNOSIS IS GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ISYMM ASPHERIC INTRAOCULAR LENS | HQL | HOYA SURGICAL OPTICS, INC. | FC-60AD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Required Intervention |