FDA Adverse Event
Malfunction
Summary report: N
CIBA VISION MEMORY LENS
MDR report key: 950024
·
Received April 20, 2007
Report
- Report Number
- 2648694-2007-00007
- Event Type
- Malfunction
- Date Received
- April 20, 2007
- Date of Event
- August 16, 2006
- Report Date
- March 20, 2007
- Manufacturer
- CIBA VISION CORP
- Product Code
- HQZ
- PMA / PMN Number
- p960036
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HISTORY RECORDS & STERILITY RECORDS HAVE BEEN REVIEWED BY MANUFACTURING AND FOUND TO BE IN COMPLIANCE.
Description of Event or Problem · 1
A SURGEON REPORTED THAT A MEMORY LENS IMPLANTED IN THE RIGHT EYE OF AN UNSPECIFIED PATIENT HAS OPAQUE ANTERIOR SURFACE NOTED SINCE 2006. A YAG WAS PERFORMED (DATE NOT PROVIDED) WITH NO IMPROVEMENT. AN IOL EXCHANGE IS BEING CONSIDERED. REQUEST HAS BEEN MADE FOR ADDITIONAL INFORMATION, HOWEVER NO FURTHER INFORMATION HAS BEEN PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CIBA VISION MEMORY LENS | INTRAOCULAR LENS | HQZ | CIBA VISION CORP | U9405 | M547197 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | NONE REPORTED |