FDA Adverse Event
Injury
Summary report: N
AKREOS ADVANCED OPTICS ASPHERIC LENS
MDR report key: 2030713
·
Received March 18, 2011
Report
- Report Number
- 1119279-2011-00063
- Event Type
- Injury
- Date Received
- March 18, 2011
- Date of Event
- December 1, 2010
- Report Date
- February 16, 2011
- Manufacturer
- BAUSCH & LOMB
- Product Code
- HQL
- PMA / PMN Number
- P060022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EVAL: THE RETURNED LENS WAS RECEIVED INSIDE THE DELIVERY DEVICE, LOCATED IN THE COMPRESSION ZONE OF THE TRANSITION CELL OF THE DELIVERY DEVICE. IT WAS NOTED THAT ONE HAPTIC WAS BENT BACKWARDS. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE OBSERVED DAMAGE. THE CAUSE OF THE DAMAGE CANNOT BE DETERMINED.
Description of Event or Problem · 1
THE SURGEON REPORTS PERFORMING CATARACT SURGERY WITH ATTEMPTED IMPLANTATION OF AN AKREOS AO60G INTRAOCULAR LENS USING AN AI-28 DELIVERY DEVICE. INTRAOPERATIVELY THE SURGEON NOTED A POSTERIOR CAPSULAR TEAR. THE AO60G LENS WAS THEN REPLACED WITH AN LI61AO LENS. ACCORDING TO THE SURGEON, THE PT'S CURRENT PROGNOSIS IS GOOD. REFERENCE MDR#: 1119279-2011-00064.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AKREOS ADVANCED OPTICS ASPHERIC LENS | INTRAOCULAR LENS | HQL | BAUSCH & LOMB | AO60G | 1935604 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Other | AI-28 DELIVERY DEVICE. |