FDA Adverse Event
Injury
Summary report: N
AKREOS ADVANCE ASPHERIC LENS
MDR report key: 1940872
·
Received December 23, 2010
Report
- Report Number
- 1119279-2010-00143
- Event Type
- Injury
- Date Received
- December 23, 2010
- Report Date
- December 2, 2010
- Manufacturer
- BAUSCH & LOMB
- Product Code
- HQL
- PMA / PMN Number
- P060022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- 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. THE INTRAOCULAR LENS REMAINS IMPLANTED. (B)(4).
Description of Event or Problem · 1
THE SURGEON REPORTS PERFORMING CATARACT SURGERY WITH IMPLANTATION OF THE AKREOS ADAPT-AOT INTRAOCULAR LENS IN THE LEFT EYE USING THE VISCOJECT 1.8 DELIVERY DEVICE. POSTOPERATIVELY, INFLAMMATION OF THE DESCEMET WAS FOUND AND AN ANTI-INFLAMMATORY AND ANTIBIOTIC REGIMEN WAS ADMINISTERED. THE PT'S CONDITION IS IMPROVING WITH A REDUCTION OF INFLAMMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AKREOS ADVANCE ASPHERIC LENS | INTRAOCULAR LENS | HQL | BAUSCH & LOMB | ADAPT-AOT | 5016243 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R | VISCOJECT 1.8 DELIVERY DEVICE (B&L) |