FDA Adverse Event
Injury
Summary report: N
EZ-28 DELIVERY SYSTEM
MDR report key: 2792268
·
Received October 12, 2012
Report
- Report Number
- 1119279-2012-00243
- Event Type
- Injury
- Date Received
- October 12, 2012
- Date of Event
- September 5, 2012
- Report Date
- September 14, 2012
- Manufacturer
- BAUSCH + LOMB
- Product Code
- MSS
- PMA / PMN Number
- K970727
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
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 LI61AOR INTRAOCULAR LENS WAS INSERTED USING A EZ-28 DELIVERY DEVICE AND REMOVED INTRAOPERATIVELY DUE TO CAPSULAR RUPTURE. THE INCISION WAS ENLARGED AND SUTURES WERE REQUIRED TO CLOSE THE WOUND. NO ADDITIONAL LENS WAS IMPLANTED. THIS EVENT IS RELATED TO THE PT'S LEFT EYE. ADDITIONAL INFO HAS BEEN REQUESTED, BUT HAS NOT BEEN RECEIVED. PLEASE REFERENCE MDR# 1119279-2012-00242 FOR THE INTRAOCULAR LENS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EZ-28 DELIVERY SYSTEM | MSS/IOL INSERTER/INJECTOR | MSS | BAUSCH + LOMB | EZ-28 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | SILICONE INTRAOCULAR LENS (B+L), LI61AO |