FDA Adverse Event
Injury
Summary report: N
SOFPORT ADVANCED OPTIC LENS
MDR report key: 3060336
·
Received April 11, 2013
Report
- Report Number
- 1119279-2013-00109
- Event Type
- Injury
- Date Received
- April 11, 2013
- Date of Event
- March 11, 2013
- Report Date
- March 12, 2013
- Manufacturer
- BAUSCH & LOMB
- Product Code
- HQL
- PMA / PMN Number
- P910061
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE LENS HAS BEEN RETURNED TO BAUSCH & LOMB FOR EVALUATION. 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 HAPTIC DAMAGE. THE INCISION WAS ENLARGED TO REMOVE THE LENS, AND ANOTHER LENS WAS IMPLANTED SUCCESSFULLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. PLEASE REFERENCE MDR# 1119279-2013-00110 FOR THE DELIVERY DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 155394 | SOFPORT ADVANCED OPTIC LENS | HQL/INTRAOCULAR LENS | HQL | BAUSCH & LOMB | LI61AOR | 4234603 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Other | DZ-28 DELIVERY SYSTEM |