BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 1772252 · Received July 22, 2010

    Report

    Report Number
    1119421-2010-00854
    Event Type
    Injury
    Date Received
    July 22, 2010
    Date of Event
    May 1, 2010
    Report Date
    June 22, 2010
    Manufacturer
    ALCON RESEARCH, LTD/HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 06/24/2010, 07/13/2010 AND 07/19/201 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. MEDICAL RECORDS WERE RECEIVED ON 06/22/2010. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "MYOPIC SURPRISE" (POSTOPERATIVE REFRACTION, UNEXPECTED); "BLURRY INTERMEDIATE AND DISTANCE VISION" (BLURRED VISION). PRODUCT PROBLEM(S): "NONE REPORTED" (NO INFORMATION [IOL (INTRAOCULAR LENS) IMPLANT]). AN OPTOMETRIST REPORTED A PATIENT WITH A MYOPIC SURPRISE FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. MEDICAL RECORDS WERE REQUESTED AND RECEIVED. ACCORDING TO THE MEDICAL RECORDS THE PATIENT HAS A HISTORY OF DRY EYES AND EYE TRAUMA IN (B)(6) 2010 (PRE-EXISTING). FOLLOWING THE IOL IMPLANT PROCEDURE, THE PATIENT REPORTED EXPERIENCING BLURRY INTERMEDIATE AND DISTANCE VISION. THE INTERMEDIATE VISION IMPROVED, BUT HIS DISTANCE VISION REMAINED BLURRY. POSTERIOR CAPSULE OPACIFICATION WAS NOTED. THE IOL WAS EXCHANGED FOR THE SAME MODEL, DIFFERENT POWER IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD/HUNTINGTON SN6AT3 10972324

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention