FDA Adverse Event
Injury
Summary report: N
AKREOS ADAPT ADVANCED OPTICS LENS
MDR report key: 1971444
·
Received January 21, 2011
Report
- Report Number
- 1119279-2011-00015
- Event Type
- Injury
- Date Received
- January 21, 2011
- Date of Event
- August 1, 2008
- Report Date
- December 3, 2010
- Manufacturer
- BAUSCH & LOMB
- Product Code
- HQL
- PMA / PMN Number
- P060022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RS
- 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. ACCORDING TO THE SURGEON, OPACIFICATION DEVELOPED DUE TO LASER PHOTO COAGULATION OF THE RETINA. (B)(4).
Description of Event or Problem · 1
THE SURGEON REPORTS PERFORMING BILATERAL CATARACT SURGERY WITH IMPLANTATION OF THE ADAPT-AO INTRAOCULAR LENS. THIS REPORT REFERS TO THE RIGHT EYE. POSTOPERATIVELY, LASER COAGULATION OF THE RETINA WAS PERFORMED. AT AN UNIDENTIFIED TIME POINT OPACIFICATIONS DESCRIBED AS GLISTENINGS BY THE SURGEON WERE NOTED IN THE CENTER OF THE OPTIC. IT IS PLANNED TO EXPLANT THE LENS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AKREOS ADAPT ADVANCED OPTICS LENS | INTRAOCULAR LENS | HQL | BAUSCH & LOMB | ADAPT-AO | 1807723 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |