BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 3223722 · Received July 10, 2013

    Report

    Report Number
    1119421-2013-00739
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 13, 2013
    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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE LENS WAS RETURNED IN PIECES. SOLUTION IS DRIED ON THE LENS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE FOR THE REPORTED COMPLAINT. EXACT FOCAL LENGTH/RESOLUTION MEASUREMENTS COULD NOT BE OBTAINED DUE TO THE OPTIC DAMAGE. HOWEVER, THE LENS IS WITHIN THE 20.5 DIOPTER RANGE (LENS RETURNED WITH A LENS CASE FOR A 19.5 DIOPTER LENS). DAMAGE WAS OBSERVED, WHICH DUE TO THE CONDITION OF THE RETURNED SAMPLE IS MOST LIKELY RELATED TO CUSTOMER HANDLING. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADD'L INFO. A COMPLETED QUESTIONAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED AN INTRAOCULAR LENS (IOL) IMPLANT WAS EXCHANGED DUE TO THE PT EXPERIENCING BLURRY VISION. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314791 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AD1 12183537

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention