FDA Adverse Event
Injury
Summary report: N
CRYSTALENS
MDR report key: 1153103
·
Received September 8, 2008
Report
- Report Number
- 2031924-2008-00276
- Event Type
- Injury
- Date Received
- September 8, 2008
- Date of Event
- September 21, 2007
- Report Date
- July 16, 2008
- Manufacturer
- EYEONICS, INC.
- Product Code
- HQL
- PMA / PMN Number
- P030002
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS.
Description of Event or Problem · 1
THE PT REPORTS UNDERGOING CATARACT SURGERY WITH IMPLANTATION OF THE CRYSTALENS IN THE LEFT EYE. POSTOPERATIVELY, THE PT REPORTS NOT BEING ABLE TO ACCOMMODATE FOR DISTANCE VISION AND HAS DIFFICULTY WITH NIGHT DRIVING. THE PT REPORTS HAVING PRE-EXISTING ADIE'S PUPIL. ADDITIONAL INFO HAS BEEN REQUESTED FORM THE PHYSICIAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CRYSTALENS | INTRAOCULAR LENS | HQL | EYEONICS, INC. | AT50SE | 008065 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Other |