FDA Adverse Event
Injury
Summary report: N
EZ-28 DELIVERY SYSTEM
MDR report key: 2895018
·
Received December 27, 2012
Report
- Report Number
- 1119279-2012-00340
- Event Type
- Injury
- Date Received
- December 27, 2012
- Report Date
- November 29, 2012
- Manufacturer
- BAUSCH & LOMB
- Product Code
- MSS
- PMA / PMN Number
- K970727
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, 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 INTRAOCULAR LENS WAS REMOVED INTRAOPERATIVELY DUE TO HAPTIC DAMAGE NOTED DURING INSERTION. THE INCISION WAS ENLARGED. ANOTHER LENS OF THE SAME MODEL WAS IMPLANTED SUCCESSFULLY. PLEASE REFERENCE MDR# 1119279-2012-003339 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 | Other | LI61A0R SOFTPORT INTRAOCULAR LENS (B+L) |