BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 4223682 · Received October 31, 2014

    Report

    Report Number
    1119421-2014-00863
    Event Type
    Injury
    Date Received
    October 31, 2014
    Date of Event
    July 1, 2014
    Report Date
    October 1, 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
    GA, US
    Reporter Occupation
    NURSE

    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 HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION BY PHONE AND FAX. AN INCOMPLETE QUESTIONNAIRE WAS RETURNED (PAGE ONE WAS MISSING). PAGE ONE HAS BEEN REQUESTED FROM REPORTER. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT FOLLOWING BILATERAL LENS (IOL) IMPLANT PROCEDURES, A PATIENT WAS INTOLERANT TO THE LENS AND STATED TO THE SURGEON "I CAN'T SEE, IT LOOKS LIKE I'M LOOKING THROUGH VASELINE". THE IOL WAS EXCHANGED FOUR MONTHS LATER FOR ANOTHER LENS MODEL. IN A FOLLOW UP, THE SURGEON REPORTED A POSTERIOR CAPSULE OPACITY (PCO) WAS OBSERVED PRIOR TO THE IOL EXCHANGE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698055 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH LTD./HUNTINGTON SN6AD1 12241683

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention VISCOAT