BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 3925536 · Received June 18, 2014

    Report

    Report Number
    1119421-2014-00468
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    January 1, 2013
    Report Date
    May 22, 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
    KS, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADD'L INFO BY PHONE, FAX AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN REC'D. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED A PATIENT WHO EXPERIENCED 3-D VISION FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANTS, IMPACTING HER ABILITY TO WORK. IN A F/U, A NURSE REPORTED BILATERAL YAG CAPSULOTOMIES WERE PERFORMED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356754 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention