FDA Adverse Event
Injury
Summary report: N
AKREOS FIT INTRAOCULAR LENS
MDR report key: 1991089
·
Received February 11, 2011
Report
- Report Number
- 1119279-2011-00028
- Event Type
- Injury
- Date Received
- February 11, 2011
- Date of Event
- January 13, 2011
- Report Date
- January 15, 2011
- Manufacturer
- BAUSCH & LOMB
- Product Code
- HQL
- PMA / PMN Number
- P060022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- 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. (B)(4).
Description of Event or Problem · 1
THE PHYSICIAN REPORTS THAT SEVERAL YEARS AFTER PERFORMING CATARACT SURGERY WITH IMPLANTATION OF THE AKREOS INTRAOCULAR LENS, OPACIFICATION OF THE LENS WAS NOTED WHICH INCREASED OVER TIME AND LED TO SIGNIFICANT VISUAL IMPAIRMENT OF THE PATIENT. ADD'L INFO HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AKREOS FIT INTRAOCULAR LENS | INTRAOCULAR LENS | HQL | BAUSCH & LOMB | AKREOS FIT | 7920528 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |