FDA Adverse Event
Injury
Summary report: N
ISYMM ASPHERIC INTRAOCULAR LENS
MDR report key: 1477023
·
Received September 16, 2009
Report
- Report Number
- 3006723646-2009-00004
- Event Type
- Injury
- Date Received
- September 16, 2009
- Date of Event
- August 18, 2009
- Report Date
- September 16, 2009
- Manufacturer
- HOYA SURGICAL OPTICS, INC.
- Product Code
- HQL
- PMA / PMN Number
- P080004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
HOYA SURGICAL OPTICS, INC. (HSO) HAS BEEN UNABLE TO CONTACT THE PHYSICIAN DESPITE SEVERAL ATTEMPTS. SINCE HSO IS UNABLE TO CONFIRM THAT THE LENS DID NOT CAUSE A SERIOUS INJURY, WE ARE CLASSIFYING THIS EVENT, FOR THE MOMENT, AS A SERIOUS INJURY.
Description of Event or Problem · 1
LENS EXPLANTED DUE TO TEAR IS CAPSULAR BAG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ISYMM ASPHERIC INTRAOCULAR LENS | HQL | HOYA SURGICAL OPTICS, INC. | FY-60AD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention |