FDA Adverse Event
Injury
Summary report: N
CLARIFLEX
MDR report key: 3061227
·
Received April 16, 2013
Report
- Report Number
- 2648035-2013-00180
- Event Type
- Injury
- Date Received
- April 16, 2013
- Date of Event
- November 20, 2006
- Report Date
- March 25, 2013
- Manufacturer
- ABBOTT MEDICAL OPTICS
- Product Code
- HQL
- PMA / PMN Number
- P880081
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
CORRECTED DATA: MODEL #: CLRFLXC. CATALOG #: CLRFLXC. SERIAL #: UNKNOWN. EXPIRATION DATE: UNKNOWN. IF IMPLANTED, GIVE DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED BY A PATIENT THAT SHE HAS BEEN EXPERIENCING SENSITIVITY TO LIGHT EVER SINCE THE EXPLANT OF HER INTRAOCULAR LENSES IN 2006. THE PATIENT HAS SEEN MULTIPLE DOCTORS AND STATED THAT SHE HAS BEEN TOLD SHE HAS DRY EYES. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 162676 | CLARIFLEX | MONOFOCAL IOLS | HQL | ABBOTT MEDICAL OPTICS | CLRFLXB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Other |