BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 3001560 · Received March 11, 2013

    Report

    Report Number
    1119421-2013-00252
    Event Type
    Injury
    Date Received
    March 11, 2013
    Date of Event
    January 1, 2013
    Report Date
    February 11, 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
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE 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. NOT ENOUGH INFORMATION WAS PROVIDED FROM THE ACCOUNT FOR FURTHER INVESTIGATION. NO REPORTER CONTACT INFORMATION WAS PROVIDED SINCE THE EVENT WAS RECEIVED THROUGH SOCIAL MEDIA; THEREFORE, NO FOLLOW UP COULD BE CONDUCTED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THROUGH SOCIAL MEDIA THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE OVER ONE YEAR AGO, THE CONSUMER HAS DIFFICULTY READING UNLESS THE ROOM IS WELL LIT. READING IN LOW LIGHT CONDITIONS, SUCH AS A MENU IN A RESTAURANT, IS VERY DIFFICULT. AT NIGHT THE CONSUMER REPORTED SEEING EIGHT RINGS AROUND EVERY LIGHT. THE CONSUMER REPORTED THEIR VISUAL ACUITY WAS BETTER BEFORE THE SURGERY WHEN WEARING GLASSES. NO REPORTER CONTACT INFORMATION WAS PROVIDED SINCE THE EVENT WAS RECEIVED THROUGH SOCIAL MEDIA; THEREFORE, NO FOLLOW UP COULD BE CONDUCTED. 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
    101722 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other