BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 3925416 · Received June 18, 2014

    Report

    Report Number
    1119421-2014-00460
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    December 4, 2013
    Report Date
    May 23, 2014
    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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED WITH SOLUTION AND WHAT THAT APPEARS TO BE BLOOD DRIED ON THE LENS. HAPTIC AND OPTIC DAMAGE WERE OBSERVED. THE LENS WAS TORN INTO PIECES. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE QUESTIONNAIRE INDICATES THE USE OF A CARTRIDGE, A HANDPIECE AND VISCOELASTIC. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED FOR THE MONARCH LOT BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. THE VISCOELASTIC NOT AN APPROVED VISCOELASTIC FOR THIS LENS/CARTRIDGE COMBINATION. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE FOR THE COMPLAINT OF GLARE, IMPAIRED VISION. A LENS BENCH TEST COULD NOT BE CONDUCTED DUE TO THE CONDITION OF THE RETURNED PRODUCT. THE EXPLANTED LENS WAS DAMAGED AND THIS DAMAGE MAY BE RELATED TO A FAILURE TO FOLLOW THE DFU. THE FILE INDICATES THE USE OF AN UNAPPROVED VISCOELASTIC WITH THE LENS/CARTRIDGE COMBINATION. DUE TO VARYING VISCOSITY, THE USE OF UNAPPROVED VISCOELASTICS MAY RESULT IN LENS DELIVERY DIFFICULTIES OR PRODUCT DAMAGE. THE QUESTIONNAIRE INDICATED THAT THE IOL DID NOT CONTRIBUTE TO THE EVENT. HOWEVER, A ROOT CAUSE FOR THE EVENT WAS NOT PROVIDED. THE LENS WAS EXCHANGED FOR AN ANOTHER LENS OF A DIFFERENT MODEL OF A LESSER DIOPTER. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFO BY PHONE, FAX AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    A TECHNICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PT EXPERIENCED DYSPHOTOPSIA AND GLARE. THE LENS WAS EXCHANGED. AN UNAPPROVED VISCOELASTIC WAS USED DURING THE IMPLANT PROCEDURE. IN THE SURGEON'S OPINION, THE DEVICE DID NOT CAUSE/CONTRIBUTE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356742 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN6AD1 12141177

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention MONARCH CARTRIDGE| HEALON VISCOELASTIC| MONARCH HANDPIECE