BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 3812600 · Received May 7, 2014

    Report

    Report Number
    1119421-2014-00321
    Event Type
    Injury
    Date Received
    May 7, 2014
    Date of Event
    December 1, 2013
    Report Date
    April 11, 2014
    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
    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 PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAS BEEN ONE SIMILAR COMPLAINT REPORTED IN THE LOT NUMBER. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADD'L INFO BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A PT EXPERIENCED BLURRY VISION. THE LENS WAS EXCHANGED FIVE MONTHS LATER FOR A DIFFERENT MODEL AND POWER IOL. IN A FOLLOW UP, A SURGICAL COORDINATOR REPORTED THE PT ALSO EXPERIENCED VISUAL DISTORTION AND DIPLOPIA. THE SYMPTOMS RESOLVED FOLLOWING THE IOL EXCHANGE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276666 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AD1 12185062

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention