FDA Adverse Event
Injury
Summary report: N
AKREOS MICRO INCISION INTRAOCULAR LENS
MDR report key: 3875266
·
Received May 28, 2014
Report
- Report Number
- 1119279-2014-00115
- Event Type
- Injury
- Date Received
- May 28, 2014
- Report Date
- April 29, 2014
- Manufacturer
- BAUSCH + LOMB
- Product Code
- HQL
- PMA / PMN Number
- P060022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE LENS REMAINS IMPLANTED THEREFORE IT IS NOT AVAILABLE FOR EVAL. INVESTIGATION OF THIS EVENT IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING F/U EXAM WITH SLIT LAMP A WHITE MEMBRANE AROUND THE IOL WAS DETECTED. THE DOCTOR SUSPECTS THE EVENT AS TASS (TOXIC ANTERIOR SEGMENT SYNDROME). TREATMENT INCLUDES ANTIBIOTICS AND ANTERIOR CHAMBER IRRIGATION. THIS REPORT IS IN REFERENCE TO THE PT'S RIGHT EYE. REF 1119279-2014-00114 FOR THE PT'S LEFT EYE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 314528 | AKREOS MICRO INCISION INTRAOCULAR LENS | HQL; INTRAOCULAR LENS | HQL | BAUSCH + LOMB | MI60 | 1112605 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Other |