BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2705871 · Received August 17, 2012

    Report

    Report Number
    1119421-2012-01022
    Event Type
    Injury
    Date Received
    August 17, 2012
    Date of Event
    January 1, 2009
    Report Date
    July 17, 2012
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 MFG DOCUMENTATION. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. NOT ENOUGH INFO WAS PROVIDED FROM THE REPORTER TO PROPERLY COMPLETE AN INVESTIGATION. ADD'L INFO WAS REQUESTED BY PHONE, FAX AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED. ROENSCH A, CHARTON J, BLOMQUIST P, AGGARWAL N, MCCULLEY J. RESIDENT EXPERIENCE WITH TORIC AND MULTIFOCAL INTRAOCULAR LENSES IN A PUBLIC COUNTY HOSPITAL SYSTEM. J CATARACT REFRACT SURG 2012; 38:793. (B)(4).

    Description of Event or Problem · 1

    IN A JOURNAL ARTICLE, THE AUTHORS PRESENTED THE OUTCOMES OF TORIC AND MULTIFOCAL INTRAOCULAR LENS (IOL) IMPLANT PROCEDURES PERFORMED BY THE RESIDENT SURGEONS. THE FIRST PT WAS BILATERALLY IMPLANTED. FOLLOWING THE INITIAL IMPLANT PROCEDURES, THE PT WAS NOTED TO HAVE AN UNEXPECTED OUTCOME WITH MILD MYOPIA AND RESIDUAL ASTIGMATISM IN THE LEFT EYE (OS). THE RIGHT EYE (OD) WAS NOTED TO BE DISLOCATED POSTOPERATIVELY. THE LENS FOR THE OD WAS EXCHANGED FOR A DIFFERENT MODEL LENS WHICH WAS PLACED IN THE CILIARY SULCUS. THERE ARE NINE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS ARTICLE. THIS REPORT IS FOR THE FIRST PT, LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD / HUNTINGTON SN6AD3 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other MONARCH CARTRIDGE| HANDPIECE| DUOVISC