FDA Adverse Event
Injury
Summary report: N
CRYSTALENS
MDR report key: 1991020
·
Received February 11, 2011
Report
- Report Number
- 2031924-2011-00033
- Event Type
- Injury
- Date Received
- February 11, 2011
- Report Date
- January 14, 2011
- Manufacturer
- BAUSCH + LOMB
- Product Code
- NAA
- PMA / PMN Number
- P030002
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS THAT RELATE TO THE REPORTED ISSUE.
Description of Event or Problem · 1
THE SURGEON REPORTS PERFORMING CATARACT SURGERY WITH IMPLANTATION OF THE CRYSTALENS INTRAOCULAR LENS. POSTOPERATIVELY, THE SURGEON NOTED THAT THE LENS WAS MALPOSITIONED. EXPLANTATION AND REPLACEMENT OF THE LENS IS PLANNED. ADDITIONAL INFO HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CRYSTALENS | INTRAOCULAR LENS | NAA | BAUSCH + LOMB | AT50SE | 013489 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |