BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2844558 · Received November 16, 2012

    Report

    Report Number
    1119421-2012-01406
    Event Type
    Injury
    Date Received
    November 16, 2012
    Date of Event
    July 1, 2012
    Report Date
    October 18, 2012
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: LENS WAS RETURNED IN A NON ALCON LENS CASE WITH SOLUTION, BLOOD, BROKEN HAPTICS AND TORN, SCRATCHED OPTIC DAMAGE. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. A LENS BENCH TEST COULD NOT BE PERFORMED ON THE LENS DUE TO THE OPTIC DAMAGE, OUR OBSERVATION REASONABLY SUGGESTS THAT IT IS NOT MANUFACTURED RELATED. DUE TO THE PRESENCE OF THE SURGICAL SOLUTION AND BLOOD, THE DAMAGE IS MOST LIKELY CUSTOMER RELATED. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFO. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXCHANGED DUE TO THE PT EXPERIENCING BLURRED VISION. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AD1 12109101

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention