BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC SINGLEPIECE IOL

    MDR report key: 6115185 · Received November 18, 2016

    Report

    Report Number
    1119421-2016-01616
    Event Type
    Injury
    Date Received
    November 18, 2016
    Date of Event
    October 11, 2016
    Report Date
    January 31, 2017
    Manufacturer
    ALCON RESEARCH, LTD. - HUNTINGTON
    Product Code
    MJP
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS RETURNED FOR ANALYSIS, HAPTIC AND OPTIC DAMAGE WAS OBSERVED. THE OPTIC IS TOO DAMAGED TO CONDUCT A CHECK FOR THE OPTICAL RESOLUTION OR THE DIOPTER OF THE LENS. SOLUTION WAS OBSERVED ON THE RETURNED PRODUCT. ADDITIONAL INFORMATION WAS PROVIDED ON THE ATTACHED QUESTIONNAIRE, WHICH INDICATED A QUALIFIED CARTRIDGE AND A QUALIFIED HANDPIECE WERE USED WITH VISCOELASTIC. ONLY THE ONE VISCOELASTIC FROM THE REPORTED DUOPACK IS QUALIFIED, THE OTHER VISCOELASTIC IS A NON-QUALIFIED VISCOELASTIC FOR THIS LENS/CARTRIDGE/HANDPIECE COMBINATION. NOT ENOUGH INFORMATION WAS PROVIDED TO CONDUCT A REVIEW ON THE CARTRIDGE LOT. A ROOT CAUSE COULD NOT BE DETERMINED FOR VISION ISSUES COMBINED. ALL LENSES ARE 100% INSPECTED FOR COSMETIC ATTRIBUTES AND THE DAMAGE EXHIBITED BY THE RETURNED COMPLAINT SAMPLE WOULD NOT HAVE MET ALCON¿S RELEASE CRITERIA. BASED ON OUR OBSERVATION, AND THE REVIEW OF MANUFACTURING RECORDS, IT CAN BE REASONABLY CONCLUDED THAT THE DAMAGE IS NOT MANUFACTURING RELATED. DUE TO THE PRESENCE OF SURGICAL SOLUTION AND THE CONDITION OF THE RETURNED SAMPLE, THE DAMAGE IS MOST LIKELY RELATED TO CUSTOMER HANDLING. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE PRODUCT HISTORY AND BATCH RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A CERTIFIED SURGICAL TECHNICIAN (CST) REPORTED AN INTRAOCULAR LENS (IOL) THAT WAS EXCHANGED DUE TO THE TRAILING HAPTIC THAT WAS NOTED TO BE TORN. ADDITIONAL INFORMATION WAS PROVIDED BY THE CST, REPORTED THAT THE EVENT RESOLVED WITH TREATMENT. ACCORDING TO THE CST, IN THE SURGEON'S OPINION HE BELIEVES THAT THE HAPTIC OF THE IOL WAS DAMAGED. POSTOPERATIVE INFORMATION WAS NOT PROVIDED AS THE POSTOPERATIVE EXAM WAS PERFORMED AT A DIFFERENT FACILITY. THE PATIENT REASON FOR REQUEST OF AN EXPLANTATION WAS DOCUMENTED AS "CORRECT VISION" AND THE CLINICAL REASON WAS DOCUMENTED AS "TORN HAPTIC".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764234 ACRYSOF IQ TORIC SINGLEPIECE IOL LENS, INTRAOCULAR, TORIC OPTICS MJP ALCON RESEARCH, LTD. - HUNTINGTON SN6AT3 12205032

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other| R DUOVISC| LIDOCAINE