BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 3962652 · Received July 16, 2014

    Report

    Report Number
    1119421-2014-00544
    Event Type
    Injury
    Date Received
    July 16, 2014
    Date of Event
    January 1, 2012
    Report Date
    June 19, 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
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. 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. THIS FILE IS FOR THE SECOND EYE. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. NOT ENOUGH INFO WAS PROVIDED FROM THE ACCOUNT FOR FURTHER INVESTIGATION. ADDITIONAL INFO HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A DIRECTOR REPORTED THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT PROCEDURES, A PT DEVELOPED GLAUCOMA AND "VISION LOSS". THE PT WAS REFERRED TO A SURGEON AND ADDITIONAL PROCEDURES WERE PERFORMED. IT WAS REPORTED THAT THE PT HAD DIABETIC RETINOPATHY PRIOR TO THE IOL IMPLANT PROCEDURES. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE LEFT EYE. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414973 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH LTD/HUNTINGTON UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention