BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 3126996 · Received May 21, 2013

    Report

    Report Number
    1119421-2013-00543
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    January 1, 2013
    Report Date
    April 22, 2013
    Manufacturer
    ALCON MANUFACTURING, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG DOCUMENTATION. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. NOT ENOUGH INFO WAS PROVIDED FROM THE ACCOUNT FOR FURTHER INVESTIGATION. NO REPORTER CONTACT INFO WAS PROVIDED SINCE THE EVENT WAS RECEIVED THROUGH SOCIAL MEDIA; THEREFORE, NO F/U COULD BE CONDUCTED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THROUGH SOCIAL MEDIA THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT PROCEDURES, THE CONSUMER HAS DOUBLE VISION AND BLURRY VISION. THE CONSUMER REPORTED HAVING TO USE A MAGNIFYING GLASS TO USE THE COMPUTER. NO REPORTER CONTACT INFO WAS PROVIDED SINCE THE EVENT WAS RECEIVED THROUGH SOCIAL MEDICAL; THEREFORE, NO F/U COULD BE CONDUCTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225283 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON MANUFACTURING, LTD. / HUNTINGTON UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other