FDA Adverse Event
Injury
Summary report: N
SILICONE ADVANCED OPTIC LENS
MDR report key: 1841619
·
Received September 16, 2010
Report
- Report Number
- 1119279-2010-00024
- Event Type
- Injury
- Date Received
- September 16, 2010
- Date of Event
- July 27, 2010
- Report Date
- July 29, 2010
- Manufacturer
- BAUSCH & LOMB
- Product Code
- HQL
- PMA / PMN Number
- P910061
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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 DAMAGED LENS HAS BEEN RETURNED TO B&L AND SUBJECTED TO VISUAL EXAMINATION, WHICH REVEALED THAT BOTH HAPTICS WERE BENT. THE CONDITION OF THE LENS IS CONSISTENT WITH LENS DAMAGE ASSOCIATED WITH LENS INJECTOR USE. (B)(4).
Description of Event or Problem · 1
THE PHYSICIAN REPORTS PERFORMING CATARACT SURGERY WITH ATTEMPTED IMPLANTATION OF THE LI61AOR INTRAOCULAR LENS. DURING INSERTION THE LENS PARTIALLY EXPELLED FROM THE INJECTOR REQUIRING INCISION ENLARGEMENT. THE LENS WAS REMOVED AND REPLACED WITH A SECOND LI61AOR IOL AND THE PATIENT'S PROGNOSIS IS EXCELLENT. REFERENCE MDR # 111979-2010-00028.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SILICONE ADVANCED OPTIC LENS | INTRAOCULAR LENS | HQL | BAUSCH & LOMB | LI61AOR | 4014010 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Required Intervention | EZ-28 INJECTOR SYSTEM (B&L) |