FDA Adverse Event
Injury
Summary report: N
SOFPORT ADVANCED OPTIC LENS
MDR report key: 2901163
·
Received January 4, 2013
Report
- Report Number
- 1119279-2013-00008
- Event Type
- Injury
- Date Received
- January 4, 2013
- Date of Event
- December 5, 2012
- Report Date
- December 5, 2012
- Manufacturer
- BAUSCH & LOMB
- Product Code
- HQL
- PMA / PMN Number
- P910061
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE LENS WAS NOT RETURNED FOR EVAL. INVESTIGATION OF THIS EVENT IS IN PROGRESS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE INTRAOCULAR LENS WAS REMOVED INTRAOPERATIVELY DUE TO THE PT'S ANATOMY (NOT SPECIFIED). THE INCISION WAS ENLARGED TO REMOVE THE LENS, AND AN ANTERIOR CHAMBER LENS WAS IMPLANTED SUCCESSFULLY. SUTURES WERE PLACED. ACCORDING TO THE DOCTOR, THERE WAS NOTHING DEFECTIVE WITH THE LENS. ADD'L INFO HAS BEEN REQUESTED. PLEASE REFERENCE MDR# 1119279-2013-00009 FOR THE DELIVERY DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 4509 | SOFPORT ADVANCED OPTIC LENS | HQL/INTRAOCULAR LENS | HQL | BAUSCH & LOMB | LI61AOR | 4222303 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | EZ-28 DELIVERY SYSTEM |