FDA Adverse Event
Injury
Summary report: N
CRYSTALENS
MDR report key: 1002041
·
Received February 25, 2008
Report
- Report Number
- 2031924-2008-00099
- Event Type
- Injury
- Date Received
- February 25, 2008
- Date of Event
- July 28, 2006
- Report Date
- January 29, 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
A PT REPORTS UNDERGOING CATARACT SURGERY WITH IMPLANTATION OF THE CRYSTALENS OD. POSTOPERATIVELY, THE PT COMPLAINED OF BLURRY VISION AND SEVERE GLARE. BCVA IS NOW 20/20, BUT NIGHTTIME GLARE HAS NOT RESOLVED. THE PT REPORTS UNDERGOING A YAG LASER PROCEDURE IN 2006 AND UNDERGOING LASIK SURGERY IN 2007. ADDITIONAL INFO WAS REQUESTED FROM THE IMPLANTING PHYSICIAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CRYSTALENS | INTRAOCULAR LENS | HQL | EYEONICS, INC. | AT45SE | 003417 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Other |