FDA Adverse Event
Injury
Summary report: N
SENSAR
MDR report key: 3253354
·
Received July 29, 2013
Report
- Report Number
- 2648035-2013-00310
- Event Type
- Injury
- Date Received
- July 29, 2013
- Date of Event
- May 26, 2009
- Report Date
- July 12, 2013
- Manufacturer
- ABBOTT MEDICAL OPTICS
- Product Code
- HQL
- PMA / PMN Number
- P980040
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
DATE OF EVENT IS (B)(6) 2009.EXPIRATION DATE IS 01-DEC-2013.ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.
Description of Event or Problem · 1
A CONSUMER REPORTED THAT SHE EXPERIENCES SIGNIFICANT ''GLARE PROBLEMS'' THAT BOTHER HER SIGNIFICANTLY WHEN SHE WATCHES TV, RIDES IN OR DRIVE A CAR, GO INTO THE SUN OR ARTIFICIAL LIGHT, HAVE ANYTHING SHINY REFLECT THE LIGHT. SHE REPORTED HAVING SEEN TWO PHYSICIANS FOR HER EVENT AND HAS BEEN ASSURED THE LENS IS POSITIONED PROPERLY. THE LENS REMAINS IMPLANTED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 353373 | SENSAR | MONOFOCAL IOLS | HQL | ABBOTT MEDICAL OPTICS | AR40E |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Other |