FDA Adverse Event
Injury
Summary report: N
CRYSTALENS
MDR report key: 1153094
·
Received September 8, 2008
Report
- Report Number
- 2031924-2008-00273
- Event Type
- Injury
- Date Received
- September 8, 2008
- Date of Event
- June 24, 2008
- Report Date
- August 13, 2008
- Manufacturer
- EYEONICS, INC.
- Product Code
- HQL
- PMA / PMN Number
- P030002
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT
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 RIGHT EYE. POSTOPERATIVELY, THE PT REPORTS THAT THE CRYSTALENS FAILED TO PROVIDE ACCOMMODATION AND SHE REQUIRES GLASSES FOR NEAR ACTIVITIES. IN ADDITION, THE PT REPORTS EXPERIENCING DOUBLE VISION AND RECEIVED AN INJECTION TO TREAT EDEMA. THE PT WILL UNDERGO A YAG CAPSULOTOMY FOR TREATMENT OF PCO. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE PHYSICIAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CRYSTALENS | INTRAOCULAR LENS | HQL | EYEONICS, INC. | AT52SE | 009998 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention |