FDA Adverse Event
Injury
Summary report: N
SILICONE ADVANCED OPTIC LENS
MDR report key: 1970351
·
Received January 14, 2011
Report
- Report Number
- 1119279-2011-00010
- Event Type
- Injury
- Date Received
- January 14, 2011
- Date of Event
- December 17, 2010
- Report Date
- December 17, 2010
- Manufacturer
- BAUSCH & LOMB
- Product Code
- HQL
- PMA / PMN Number
- P910061
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS THAT RELATE TO THE REPORTED ISSUE. THE DEVICE EVALUATION IS CURRENTLY IN PROGRESS. THE EVALUATION RESULTS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
THE PHYSICIAN REPORTS PERFORMING CATARACT SURGERY WITH ATTEMPTED IMPLANTATION OF THE (B)(4) INTRAOCULAR LENS. ACCORDING TO PROVIDED INFORMATION, DURING IOL INSERTION THERE WAS A POSSIBLE CAPSULE TEAR. THE LENS WAS EXPLANTED AND A VITRECTOMY WAS PERFORMED. AN ANTERIOR CHAMBER LENS WAS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SILICONE ADVANCED OPTIC LENS | INTRAOCULAR LENS | HQL | BAUSCH & LOMB | LI61AOR | 4023211 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |