BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 3841041 · Received May 14, 2014

    Report

    Report Number
    1119421-2014-00353
    Event Type
    Injury
    Date Received
    May 14, 2014
    Date of Event
    January 1, 2013
    Report Date
    April 18, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; LENS REMAINS IMPLANTED. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO BE MANUFACTURING DOCUMENTATION. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADD'L INFO BY PHONE, FAX AND EMAIL. A COMPLETED QUESTIONNAIRE WAS NOT RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A PT EXPERIENCED AN UNEXPECTED POSTOPERATIVE OUTCOME AND BLURRY VISION. THE PT HAS HAD A CONSULTATION BY THREE DIFFERENT SURGEONS DUE TO BCVA 20/40.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288033 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other