BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 3093804 · Received April 30, 2013

    Report

    Report Number
    1119421-2013-00455
    Event Type
    Injury
    Date Received
    April 30, 2013
    Date of Event
    March 7, 2013
    Report Date
    April 1, 2013
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE CUSTOMER INDICATED THE USE OF AN APPROVED CARTRIDGE AND HANDPIECE. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFO. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON (B)(4) 2013. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, IT "SEEMS LIKE I DID NOT HAVE SURGERY". THE CONSUMER REPORTED THAT HER LEFT EYE WAS CORRECTED FOR DISTANCE, BUT SHE CANNOT SEE AT ALL IN THE DISTANCE, HER VISION IS BLURRY. THE CONSUMER LATER REPORTED THAT HER NEAR VISION WAS ALSO AFFECTED. IN A F/U, THE SURGEON REPORTED HE HAD AIMED FOR PLANO WHEN PERFORMING THE CONSUMER'S IMPLANT PROCEDURE, BUT THE CONSUMER STILL HAD A REFRACTIVE ERROR. HER CORRECTED VA FOLLOWING THE PROCEDURE WAS 20/20. HE DOES NOT FEEL THE LENS CAUSED OR CONTRIBUTED TO THE EVENT. THE SURGEON REPORTED THE EVENT CONTINUES, THE CONSUMER DOES NOT DESIRE A LENS EXCHANGE FOR LASIK. SHE IS CONSIDERING BEING FITTED FOR CONTACT LENSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186940 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60WF 12156318

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other DISCOVISC| MONARCH III HANDPIECE| MONARCH D CARTRIDGE| BSS| DUOVISC