BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 3221809 · Received July 9, 2013

    Report

    Report Number
    1119421-2013-00747
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    February 1, 2013
    Report Date
    June 10, 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
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    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 PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE ARE NO OTHER COMPLAINTS REPORTED IN THE LOT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A COMPLETED QUESTIONAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER'S HUSBAND REPORTED THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY, HIS WIFE REPORTED THAT SHE COULD NOT SEE WELL WITH EITHER EYE. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT BOTH OF THE IOL'S WERE EXCHANGED FOR MONOFOCAL IOL'S BY A DIFFERENT SURGEON. THE EXACT DATE OF THE LENS EXCHANGES WERE UNKNOWN. THE CONSUMER'S HUSBAND INDICATED THAT HIS WIFE CAN SEE WELL NOW. ADDITIONAL INFORMATION WAS 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
    312515 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AD1 12161147

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention