BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 3030293 · Received March 28, 2013

    Report

    Report Number
    1119421-2013-00327
    Event Type
    Injury
    Date Received
    March 28, 2013
    Date of Event
    January 1, 2013
    Report Date
    February 27, 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
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS TO RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADD'L INFO. A COMPLETED QUESTIONNAIRE HAS BEEN REC'D. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY HER EYESIGHT WAS WORSE DISTANCE AND NEAR THAN BEFORE HER PROCEDURE. THE CONSUMER ALSO REPORTED HER BALANCE WAS EFFECTED AND HER EYE OFTEN FELT UNCOMFORTABLE. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128649 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN6AD1 12027954

    Patients

    Seq Age Sex Outcome Treatment
    1