FDA Adverse Event
Malfunction
Summary report: N
ISERT ASPHERIC INTRAOCULAR LENS
MDR report key: 1860298
·
Received September 23, 2010
Report
- Report Number
- 3006723646-2010-00094
- Event Type
- Malfunction
- Date Received
- September 23, 2010
- Date of Event
- August 26, 2010
- Report Date
- September 23, 2010
- Manufacturer
- HOYA SURGICAL OPTICS INC.
- Product Code
- HQL
- PMA / PMN Number
- P080004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
LENS WAS EXPLANTED BECAUSE THE DOCTOR DECIDED THAT A DIFFERENT POWER SHOULD BE USED. THERE IS NO DEFICIENCY WITH THE LENS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ISERT ASPHERIC INTRAOCULAR LENS | HQL | HOYA SURGICAL OPTICS INC. | PC-60AD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention |