FDA Adverse Event
Injury
Summary report: N
CRYSTALENS
MDR report key: 1352377
·
Received March 26, 2009
Report
- Report Number
- 2031924-2009-00032
- Event Type
- Injury
- Date Received
- March 26, 2009
- Date of Event
- January 12, 2009
- Report Date
- February 24, 2009
- Manufacturer
- BAUSCH & LOMB SURGICAL
- 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
A PATIENT REPORTS UNDERGOING CATARACT SURGERY WITH IMPLANTATION OF THE CRYSTALENS IN THE RIGHT EYE. IMMEDIATELY POSTOPERATIVELY, THE PATIENT COMPLAINED OF DIPLOPIA AND HAD MINOR ASTIGMATISM. THE PATIENT UNDERWENT A YAG CAPSULOTOMY FOR TREATMENT OF PCO AT ONE MONTH POSTOPERATIVELY. TWO AND A HALF MONTHS POSTOPERATIVELY, THE LENS VAULTED IN A Z CONFIGURATION WITH INCREASED MYOPIA AND CYLINDER. INTERVENTION WAS PERFORMED IN AN ATTEMPT TO REPOSITION THE LENS, HOWEVER THIS WAS NOT SUCCESSFUL. THE PATIENT IS UNDER THE CARE OF A NEW OPHTHALMOLOGIST FOR RESOLUTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CRYSTALENS | INTRAOCULAR LENS | HQL | BAUSCH & LOMB SURGICAL | AT50SE | 012861 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention |