BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 3900033 · Received May 27, 2014

    Report

    Report Number
    1119421-2014-00391
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 30, 2014
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. PILOT STUDY PRESENTED AT A PROFESSIONAL MEETING 04/28/2014. ADDITIONAL INFO HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    DURING A PROFESSIONAL MEETING, A SURGEON PRESENTED A PILOT STUDY OF 90 PATIENTS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURES, 51 HAD IOL'S FROM THIS MFR AND 39 HAD IOL'S MANUFACTURED FROM A COMPETITOR. THE DEMOGRAPHICS OF THE TWO GROUPS WERE SIMILAR. THE PATIENTS IN GROUP A WERE MORE LIKELY TO HAVE ROAD TRAFFIC ACCIDENTS AND LESS LIKELY TO DRIVE AT THE SAME SPEED OR FASTER THAN GENERAL FLOW OF TRAFFIC. THERE WAS A TENDENCY FOR GROUP A TO BE LESS LIKELY TO HAVE TRAVELED BEYOND THEIR IMMEDIATE NEIGHBOR, TO BE LESS LIKELY TO RATE THEIR QUALITY OF DRIVING AT AVERAGE OR ABOVE AND TO BE MORE LIKELY TO HAVE DIFFICULTY DRIVING AT NIGHT DUE TO GLARE, BUT THIS DID NOT REACH SIGNIFICANCE. TYPE A SUBJECTS TREND TOWARD DRIVING SLOWER AND DRIVING LESS. IT WAS REPORTED THAT FOUR PATIENTS WITH TYPE A IOL HAD ACCIDENTS. RETROSPECTIVE ANALYSIS OF PATIENTS WHO MET THE VISUAL REQUIREMENTS FOR A DRIVERS LICENSE FOLLOWING CATARACT SURGERY AND HAD BILATERAL IMPLANTATION OF THE SAME LENS. THE PATIENTS HAD AT LEAST 2 YEARS OF FOLLOW-UP. TWO GROUPS OF PATIENTS WERE IDENTIFIED; EACH WITH ONE OF TWO TYPES OF IOL'S. BOTH GROUPS WERE GIVEN THE DRIVING HABITS QUESTIONAIRE, WHICH HAS BEEN EXTENSIVELY EVALUATED BY A SINGLE INVESTIGATOR. ADDITIONAL INFO HAS BEEN REQUESTED. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311975 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60WF UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other