BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2587228 · Received May 21, 2012

    Report

    Report Number
    1119421-2012-00629
    Event Type
    Injury
    Date Received
    May 21, 2012
    Date of Event
    April 14, 2012
    Report Date
    April 18, 2012
    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

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE ROOT CAUSE COULD NOT BE IDENTIFIED BY THE INVESTIGATION. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 04/20/2012, 04/23/2012 AND 04/30/2012 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. ADDITIONAL INFORMATION WAS PROVIDED IN FOLLOW UP PHONE CALLS ON 04/23/2012 AND 05/10/2012. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT FIVE DAYS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, HER VISION WAS STILL BLURRED. THEN, TWO WEEKS FOLLOWING THE INITIAL IMPLANT PROCEDURE, THE IOL WAS EXCHANGED FOR THE SAME MODEL, DIFFERENT DIOPTER LENS. SHE REPORTED THAT HER DISTANCE VISION WAS IMPROVED, BUT HER NEAR VISION WITHIN THREE FEET WAS BLURRY. THE CONSUMER REPORTED THE SURGEON TOLD HER TO GIVE IT SOME TIME. THE CONSUMER REPORTED SHE IS UNABLE TO READ, PLAY GOLF AND SHE HAS NO DEPTH PERCEPTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE IOL THAT WAS EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN6AD1 10966234

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention