FDA Adverse Event
Injury
Summary report: N
VISCOJECT 1.8 DELIVERY SYSTEM
MDR report key: 2901179
·
Received January 4, 2013
Report
- Report Number
- 1119279-2013-00011
- Event Type
- Injury
- Date Received
- January 4, 2013
- Date of Event
- December 5, 2012
- Report Date
- December 5, 2012
- Manufacturer
- MEDICEL AG
- Product Code
- MSS
- PMA / PMN Number
- K092023
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE LENS WAS DISCARDED BY THE FACILITY AND WILL NOT BE RETURNED TO B+L FOR EVAL. INVESTIGATION OF THIS EVENT IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LENS WAS REMOVED FROM THE PT'S RIGHT EYE INTRAOPERATIVELY DUE TO CAPSULAR TEAR NOTED DURING THE ORIGINAL SURGERY. VITRECTOMY WAS PERFORMED AND ANOTHER LENS OF DIFFERENT MODEL WAS IMPLANTED SUCCESSFULLY. THE PT'S PROGNOSIS WAS REPORTED AS "DOING WELL". PLEASE REFERENCE MDR#: 119279-2013-00010 FOR THE INTRAOCULAR LENS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 4942 | VISCOJECT 1.8 DELIVERY SYSTEM | MSS/FOLDERS AND INJECTOR IOL | MSS | MEDICEL AG | LP604350 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Other | AKREOS MICRO INCISION LENS |