BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTORE

    MDR report key: 3591409 · Received January 15, 2014

    Report

    Report Number
    1119421-2014-00032
    Event Type
    Injury
    Date Received
    January 15, 2014
    Date of Event
    July 3, 2013
    Report Date
    December 19, 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
    NV, 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 HAS BEEN ONE OTHER COMPLAINT REPORTED IN THE LOT NUMBER. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFO BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS NOT RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER'S SPOUSE REPORTED THAT SINCE HIS WIFE HAD THE MULTIFOCAL INTRAOCULAR LENS (IOL) IMPLANTED, HIS WIFE OBSERVED A DARK SHADOW IN THE UPPER LEFT QUADRANT. SHE HAS ALSO OBSERVED LINES THROUGH HER VISION LIKE A ROAD MAP OR LIKE WATER RUNNING AND A SMUDGE. HER OPHTHALMOLOGIST HAS TESTED HER EYES AND SEES NOTHING WRONG. THEREFORE, SHE IS WONDERING IF THERE IS A POSSIBILITY THAT THE LENS IS DEFECTIVE, SCRATCHED OR HAS SOMETHING ON IT. ADDITIONAL INFO WAS RECEIVED FROM THE CONSUMER'S SPOUSE REPORTING THAT HIS WIFE RECALLS THE SURGEON MENTIONING HE WAS GOING TO PLACE A CONTACT LENS ON THE EYE DURING THE IMPLANT PROCEDURE, ALTHOUGH SHE DOES NOT KNOW WHY. THE FOLLOWING DAY THE CONSUMER EXPERIENCED SEVERE PAIN AND RECALLS A CRUMPLED UP CONTACT LENS COMING OUT OF HER EYE. SHE IS HAVING DIFFICULTY READING DUE TO THE DISTORTED VISION. ADDITIONAL INFO HAS BEEN REQUESTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40986 ACRYSOF RESTORE INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN6AD1 12175546

    Patients

    Seq Age Sex Outcome Treatment
    1 Other