FDA Adverse Event
Injury
Summary report: N
CRYSTALENS
MDR report key: 1111532
·
Received August 13, 2008
Report
- Report Number
- 2031924-2008-00260
- Event Type
- Injury
- Date Received
- August 13, 2008
- Date of Event
- June 2, 2008
- Report Date
- July 15, 2008
- Manufacturer
- EYEONICS, INC.
- Product Code
- HQL
- PMA / PMN Number
- P030002
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
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 PHYSICIAN REPORTS EXPLANTATION OF THE CRYSTALENS SUBSEQUENT TO A PATIENT'S COMPLAINT OF NIGHT GLARE DISTORTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE PHYSICIAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CRYSTALENS | INTRAOCULAR LENS | HQL | EYEONICS, INC. | AT50SE | 012807 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |