FDA Adverse Event
Malfunction
Summary report: N
CRYSTALENS
MDR report key: 1182325
·
Received September 29, 2008
Report
- Report Number
- 2031924-2008-00297
- Event Type
- Malfunction
- Date Received
- September 29, 2008
- Report Date
- August 21, 2008
- Manufacturer
- BAUSCH & LOMB SURGICAL
- Product Code
- HQL
- PMA / PMN Number
- P030002
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
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 ACCOUNT REPORTS THAT THE CRYSTALENS WAS NOT PACKAGED PROPERLY IN THE CASE. ADDITIONAL INFORMATION IS BEING REQUESTED FROM THE REPORTER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CRYSTALENS | INTRAOCULAR LENS | HQL | BAUSCH & LOMB SURGICAL | AT50SE | 014610 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |