BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 3152642 · Received June 5, 2013

    Report

    Report Number
    1119421-2013-00604
    Event Type
    Injury
    Date Received
    June 5, 2013
    Date of Event
    January 1, 2011
    Report Date
    May 7, 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
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT 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 ADDITIONAL INFO. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED DECREASED VISION FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT PROCEDURES. THE CONSUMER REPORTED SHE IS UNABLE TO READ SPEED LIMIT SIGNS AS WELL AS SHE SHOULD. THE CONSUMER REPORTED THE LEFT EYE IS WORSE THAN THE RIGHT EYE AND SHE HAS A YAG PROCEDURE ON BOTH EYES TO REMOVE "SCAR TISSUE." ADDITIONAL INFO HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248737 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AD1 11038294

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention