BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ RESTOR SINGLEPIECE IOL

    MDR report key: 4771682 · Received May 14, 2015

    Report

    Report Number
    1119421-2015-05373
    Event Type
    Injury
    Date Received
    May 14, 2015
    Date of Event
    February 28, 2015
    Report Date
    December 7, 2015
    Manufacturer
    ALCON RESEARCH, LTD. - HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALCON IS INVESTIGATING AN INCREASED NUMBER OF CASES OF ASEPTIC ENDOPHTHALMITIS CASES REPORTED SINCE (B)(6) 2015 IN CATARACT SURGERY PATIENTS WHO RECEIVED RESTOR® IOLS IN VARIOUS CLINICS IN (B)(6). WE TAKE THIS SITUATION VERY SERIOUSLY AND IN THE INTEREST OF PATIENT SAFETY, ARE VOLUNTARILY RECALLING RESTOR® MULTIFOCAL IOLS MANUFACTURED SPECIFICALLY FOR THE (B)(6) MARKET AND ADVISING SURGEONS IN (B)(6) WHOSE CLINICS HAVE INVENTORY OF RESTOR® IOLS TO STOP USING THESE IOLS. PRODUCT EVALUATION: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE LENS REMAINS IMPLANTED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE BEEN TWO OTHER SIMILAR COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 1

    A DOCTOR REPORTED ENDOPHTHALMITIS FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE. THE PATIENT COMPLAINED OF CLOUDY VISION AND DIFFICULTY SEEING. THE LENS REMAINS IN THE EYE. ADDITIONAL INFORMATION WAS REQUESTED.

    Description of Event or Problem · 1

    SYMPTOMS IMPROVED AFTER INITIAL MEDICAL TREATMENT. CLINICAL JUDGEMENT REGARDING INFECTIOUS OR NON-INFECTIOUS IS UNKNOWN. BACTERIUM INSPECTION WAS NOT PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317295 ACRYSOF IQ RESTOR SINGLEPIECE IOL LENS, MULTIFOCAL INTRAOCULAR MFK ALCON RESEARCH, LTD. - HUNTINGTON SN6AD1 12215201

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other