FDA Adverse Event
Injury
Summary report: N
SILICONE ADVANCED OPTIC LENS
MDR report key: 1936258
·
Received December 14, 2010
Report
- Report Number
- 1119279-2010-00124
- Event Type
- Injury
- Date Received
- December 14, 2010
- Report Date
- November 15, 2010
- Manufacturer
- BAUSCH & LOMB
- Product Code
- HQL
- PMA / PMN Number
- P910061
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDING THAT RELATE TO THE REPORTED ISSUE. ACCORDING TO THE PHYSICIAN, THE LIKELY ROOT CAUSE OF THE LENS DAMAGE CAN BE ATTRIBUTED TO THE INJECTOR WHERE THE PLUNGER TIP OVERRODE THE IOL.
Description of Event or Problem · 1
THE PHYSICIAN REPORTS PERFORMING CATARACT SURGERY WITH ATTEMPTED IMPLANTATION OF THE LI61AOR INTRAOCULAR LENS IN THE RIGHT EYE USING THE EZ-28 DELIVERY DEVICE. INTRAOPERATIVELY, LENS DAMAGE OCCURRED DUE TO THE PLUNGER OF THE INJECTOR OVERRIDING THE INTRAOCULAR LENS. INTERVENTION WAS PERFORMED IN ORDER TO ENLARGE THE INCISION AND REMOVE AND REPLACE THE LENS. A SECOND INTRAOCULAR LENS WAS IMPLANTED SUCCESSFULLY. REFERENCE MDR #1119279-2010-000125.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SILICONE ADVANCED OPTIC LENS | INTRAOCULAR LENS | HQL | BAUSCH & LOMB | LI61AOR | 4016008 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | EZ-28 DELIVERY DEVICE (B&L) |