BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 3841036 · Received May 14, 2014

    Report

    Report Number
    1119421-2014-00352
    Event Type
    Injury
    Date Received
    May 14, 2014
    Date of Event
    January 1, 2014
    Report Date
    April 18, 2014
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE LENS WAS RETURNED. DAMAGE WAS OBSERVED. SOLUTION IS DRIED ON THE LENS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THE OPTICAL SOLUTION IS ACCEPTABLE, LENS MEETS SPECIFICATION FOR FOCAL LENGTH. THE OBSERVED DAMAGE IS MOST LIKELY RELATED TO CUSTOMER HANDLING. THERE HAS BEEN ONE SIMILAR COMPLAINT REPORTED IN THE LOT NUMBER. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADD'L INFO BY PHONE, FAX AND EMAIL. A COMPLETED QUESTIONNAIRE WAS NOT RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT THREE YEARS FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A PT EXPERIENCED BLURRED VISION. THE LENS WAS EXCHANGED FOR A DIFFERENT LENS MODEL AND POWER AND A VITRECTOMY WAS PERFORMED. IN A F/U, A TECH REPORTED THE VITRECTOMY WAS PLANNED PRIOR TO THE LENS EXCHANGE PROCEDURE. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288031 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN6AD1 10875374

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention