FDA Adverse Event
Injury
Summary report: N
EZ-28 DELIVERY SYSTEM
MDR report key: 1940569
·
Received December 21, 2010
Report
- Report Number
- 1119279-2010-00149
- Event Type
- Injury
- Date Received
- December 21, 2010
- Date of Event
- December 6, 2010
- Report Date
- December 7, 2010
- Manufacturer
- BAUSCH & LOMB
- Product Code
- MSS
- PMA / PMN Number
- K970727
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PHYSICIAN REPORTS PERFORMING CATARACT SURGERY WITH ATTEMPTED IMPLANTATION OF THE (B)(4) INTRAOCULAR LENS USING THE EZ-28 DELIVERY DEVICE. INTRAOPERATIVELY, THE PHYSICIAN NOTICED THE TRAILING HAPTIC WAS BENT. INTERVENTION WAS PERFORMED IN ORDER TO ENLARGE THE INCISION AND REMOVE AND REPLACE THE LENS. A SECOND INTRAOCULAR LENS OF THE SAME MODEL AND DIOPTER WAS IMPLANTED SUCCESSFULLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. REFERENCE MDR #1119279-2010-00148.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EZ-28 DELIVERY SYSTEM | IOL INSERTER/INJECTOR | MSS | BAUSCH & LOMB | EZ-28 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | SILICONE ADVANCED OPTIC LENS (B+L) |