FDA Adverse Event
Injury
Summary report: N
CRYSTALENS HD
MDR report key: 1961008
·
Received January 11, 2011
Report
- Report Number
- 2031924-2011-00016
- Event Type
- Injury
- Date Received
- January 11, 2011
- Date of Event
- September 10, 2010
- Report Date
- December 15, 2010
- Manufacturer
- BAUSCH + LOMB
- Product Code
- NAA
- PMA / PMN Number
- P030002
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, 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 PHYSICIAN REPORTS PERFORMING CATARACT SURGERY WITH IMPLANTATION OF THE CRYSTALENS INTRAOCULAR LENS. APPROX NINE MONTHS POSTOPERATIVELY, THE INTRAOCULAR LENS VAULTED AND WAS SUBSEQUENTLY EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CRYSTALENS HD | INTRACOLAR LENS | NAA | BAUSCH + LOMB | HD520 | 015051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |