BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC SINGLEPIECE IOL

    MDR report key: 6094797 · Received November 10, 2016

    Report

    Report Number
    1119421-2016-01564
    Event Type
    Injury
    Date Received
    November 10, 2016
    Date of Event
    August 29, 2016
    Report Date
    November 10, 2016
    Manufacturer
    ALCON RESEARCH, LTD. - HUNTINGTON
    Product Code
    MJP
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; IT REMAINS IMPLANTED. THE 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 NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. (B)(4).

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AN UNEXPECTED OUTCOME WAS DISCOVERED. ADDITIONAL INFORMATION WAS PROVIDED BY A SURGICAL COUNSELOR THAT THERE WAS AN ATTEMPT TO EXCHANGE THE IOL BUT ADHESION TO THE HAPTIC MADE IT DANGEROUS RISKING ZONULAR DEHISCENSE. THE LENS REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745906 ACRYSOF IQ TORIC SINGLEPIECE IOL LENS, INTRAOCULAR, TORIC OPTICS MJP ALCON RESEARCH, LTD. - HUNTINGTON SN6AT5 12269672

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention