FDA Adverse Event
Injury
Summary report: N
AKREOS ADAPT AO MICRO INCISION LENS
MDR report key: 1980249
·
Received February 1, 2011
Report
- Report Number
- 1119279-2011-00024
- Event Type
- Injury
- Date Received
- February 1, 2011
- Date of Event
- December 14, 2010
- Report Date
- January 4, 2011
- Manufacturer
- BAUSCH & LOMB
- Product Code
- HQL
- PMA / PMN Number
- P060022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- 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. (B)(4).
Description of Event or Problem · 1
THE PHYSICIAN REPORTS PERFORMING BILATERAL CATARACT SURGERY WITH IMPLANTATION OF THE MI60G INTRAOCULAR LENS. THE SURGEON NOTED CIRCULAR SCRATCHES ON THE LENS. APPROX THREE WEEKS POSTOPERATIVELY, THE PT DEVELOPED AN INFLAMMATORY REACTION. ADDITIONAL INFO HAS BEEN REQUESTED. REFERENCE MDR: 1119279-2011-00025.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AKREOS ADAPT AO MICRO INCISION LENS | INTRAOCULAR LENS | HQL | BAUSCH & LOMB | MI60G | 1018720 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |