BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2980592 · Received February 21, 2013

    Report

    Report Number
    1119421-2013-00170
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 23, 2013
    Manufacturer
    ALCON RESEARCH, LTD / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE REVIEW INCLUDES ACCEPTANCE FOR ALL COSMETIC, OPTICAL AND FUNCTIONAL PROPERTIES OF THE PRODUCT. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAS BEEN ONE OTHER SIMILAR COMPLAINT REPORTED IN THE LOT NUMBER. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE PT DID NOT REACH GOOD VISUAL ACUITY WHICH IS CORRECTED WITH MONOFOCAL GLASSES. THE GRADUATION OF THE GLASSES AT THAT TIME WAS +0.75, HOWEVER, AT THE LAST FOLLOW-UP VISIT, THE SURGEON INDICATED THE PT NEEDED AN ADDITION OF +2.00 AND POSSIBLE PROGRESSIVE GLASSES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75224 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD / HUNTINGTON SN6AD1 12057493

    Patients

    Seq Age Sex Outcome Treatment
    1 Other