BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ RESTOR SINGLEPIECE IOL

    MDR report key: 4792726 · Received May 22, 2015

    Report

    Report Number
    1119421-2015-05438
    Event Type
    Injury
    Date Received
    May 22, 2015
    Date of Event
    January 21, 2015
    Report Date
    January 12, 2016
    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

    EVALUATION SUMMARY: BASED ON A REVIEW OF COMPLAINTS RECEIVED, A SIGNAL FOR POST-OPERATIVE INFLAMMATION WAS IDENTIFIED FOR RESTOR® IQ AND RESTOR® TORIC IOLS IN (B)(6). THE MANUFACTURING INVESTIGATION POINTED TO THE DIFFERENCE IN MANUFACTURING PROCESSES FOR THE (B)(6) MARKET AND MULTIFOCAL LENSES AS A POTENTIAL DIFFERENTIATOR. THE MANUFACTURING INVESTIGATION HAS NOT IDENTIFIED A ROOT CAUSE TO DATE. DATA ANALYSIS SO FAR HAS CONFIRMED THAT THESE COMPLAINTS ARE SIGNIFICANT AND CONCENTRATED AROUND THE (B)(6) MARKET FOR THE IDENTIFIED MULTIFOCAL LENSES. ON APRIL 13, 2015 THE IMPACTED PRODUCT WAS PUT ON VOLUNTARY HOLD IN THE (B)(6) MARKET AND ISSUANCE OF THE MARKET CAUTION LETTER. ON APRIL 16, 2015 DUE TO A SIGNIFICANT INCREASE IN REPORTS OF POST-OPERATIVE INFLAMMATION CASES REPORTED IN CATARACT SURGERY PATIENTS WHO RECEIVED THE IDENTIFIED MULTIFOCAL INTRAOCULAR LENSES (IOLS), A VOLUNTARY PRODUCT RECALL WAS ISSUED AGAINST ALL LOT NUMBERS AND MODELS OF THE IDENTIFIED MULTIFOCAL IOLS MANUFACTURED SPECIFICALLY FOR THE (B)(6) MARKET. A CORRECTIVE AND PREVENTIVE ACTION HAS BEEN INSTITUTED; THE INVESTIGATION IS ONGOING. (B)(4).

    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 JAPAN WHOSE CLINICS HAVE INVENTORY OF RESTOR® IOLS TO STOP USING THESE IOLS. EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE LENS REMAINS IMPLANTED. THE PRODUCT HISTORY AND BATCH RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. THE CARTRIDGE AND HANDPIECE 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. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: 2015-24093

    Description of Event or Problem · 1

    AN OPHTHALMOLOGIST REPORTED THAT APPROXIMATELY TWO WEEKS FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT DEVELOPED INFLAMMATION OF THE DESCEMET MEMBRANE. THE LENS REMAINS IMPLANTED. ADDITIONAL INFORMATION WAS RECEIVED, WHICH INDICATES THAT THE PATIENT EXPERIENCED DECREASED VISION ON THE FIRST POSTOPERATIVE DAY. APPROXIMATELY TWO WEEKS LATER, THE PATIENT'S PROBLEM IS DOCUMENTED AS ASEPTIC ENDOPHTHALMITIS THE PATIENT WAS TREATED WITH A SUBCONJUNCTIVAL STEROID/ANTIBIOTIC INJECTION, ANTIBIOTIC AND ANTI-INFLAMMATORY EYE DROPS. TWO ADDITIONAL STEROID INJECTIONS WERE GIVEN THE FOLLOWING TWO DAYS. THE EVENT WAS DETERMINED AS RESOLVED APPROXIMATELY FOUR MONTHS POSTOPERATIVE. THERE WAS NO BACTERIUM INSPECTION PERFORMED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED BY THE SURGEON, WHO REPORTED THAT APPROXIMATELY TWO WEEKS POSTOPERATIVE THE PATIENT ALSO EXPERIENCED HYPEREMIA, ANTERIOR CHAMBER CELLS, ANTERIOR CHAMBER FLARE AND FIBRIN. THE PATIENT'S SYMPTOMS HAVE RECOVERED. ACCORDING TO THE SURGEON, THE EVENT WAS NON-INFECTIOUS. EVEN THOUGH FIBRIN MEMBRANE WAS OBSERVED, IT DID NOT SEEM THAT AN INFECTION HAD OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335226 ACRYSOF IQ RESTOR SINGLEPIECE IOL LENS, MULTIFOCAL INTRAOCULAR MFK ALCON RESEARCH, LTD. - HUNTINGTON SN6AD1 12279107

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other TRYPAN BLUE STAIN| MONARCH II C CARTRIDGE