BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2833720 · Received November 12, 2012

    Report

    Report Number
    1119421-2012-01379
    Event Type
    Injury
    Date Received
    November 12, 2012
    Date of Event
    August 8, 2012
    Report Date
    September 7, 2012
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. 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. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON (B)(4) 2012. (B)(4).

    Description of Event or Problem · 1

    A PURCHASING PERSONNEL REPORTED AN INTRAOCULAR LENS (IOL) WITH A BROKEN HAPTIC. ADDITIONAL INFORMATION WAS RECEIVED FROM THE SURGEON WHO REPORTED THE LENS WAS REMOVED THROUGH AN ENLARGED INCISION DUE TO INCREASED VITREOUS LOSS. THE SURGEON SENT FURTHER INFORMATION THAT INDICATED THAT A POSTERIOR CAPSULE TEAR OCCURRED. AN ANTERIOR VITRECTOMY WAS PERFORMED AND THE LENS REPLACED WITH A SULCUS LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON MA60AC 12079546

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention PROVISC| MONARCH II HANDPIECE| MONARCH C CARTRIDGE| VISCOAT