BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARIFLEX

    MDR report key: 2823312 · Received November 7, 2012

    Report

    Report Number
    2648035-2012-00347
    Event Type
    Injury
    Date Received
    November 7, 2012
    Report Date
    October 11, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P880081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).PRIOR TO RELEASE TO MARKET THE INTRAOCULAR LENS MET ALL MANUFACTURING SPECIFICATIONS.ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. (B)(4): PLACEHOLDER.

    Description of Event or Problem · 1

    REPORTEDLY, THE PATIENT WAS EXPERIENCING SYMPTOMS OF VISION LOSS. THE PHYSICIAN STATED THAT THERE APPEARED TO BE "WHITE SPOTS" ON THE POSTERIOR ASPECT OF THE INTRAOCULAR LENS (IOL). THE PHYSICIAN DESCRIBED THESE "WHITE SPOTS" AS BEING "IMPLANT OPACIFICATION" AND "CALCIFIED PRECIPITATES". FURTHER DISCUSSION OF MANAGEMENT OF THE PATIENT IMPLIED THE PHYSICIAN WOULD EXCHANGE THE INTRAOCULAR LENS (IOL), STARTING WITH THE LEFT EYE FIRST. DUE TO HURRICANE (B)(6), THE EXCHANGE OF THE INTRAOCULAR LENS (IOL) IS CURRENTLY PENDING. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLARIFLEX MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS CLRFLX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other