FDA Adverse Event
Injury
Summary report: N
SILICONE ADVANCED OPTIC LENS
MDR report key: 1940310
·
Received December 17, 2010
Report
- Report Number
- 1119279-2010-00121
- Event Type
- Injury
- Date Received
- December 17, 2010
- Date of Event
- November 18, 2010
- Report Date
- November 18, 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. (B)(4).
Description of Event or Problem · 1
THE SURGEON REPORTS PERFORMING CATARACT SURGERY WITH ATTEMPTED IMPLANTATION OF THE SILICONE (B)(4) INTRAOCULAR LENS (IOL) USING THE EZ-28 DELIVERY DEVICE SYSTEM. INTRAOPERATIVELY, THE SURGEON WAS UNABLE TO PROPERLY POSITION THE IOL IN THE CAPSULAR BAG. THE IOL WAS REMOVED, A VITRECTOMY WAS PERFORMED AND AN ANTERIOR CHAMBER IOL WAS IMPLANTED SUCCESSFULLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. REFERENCE MDR #1119279-2010-000122.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SILICONE ADVANCED OPTIC LENS | INTRAOCULAR LENS | HQL | BAUSCH & LOMB | LI61AOR | 4012313 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | EZ-28 DELIVERY DEVICE (B+L) |