BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 1674641 · Received May 3, 2010

    Report

    Report Number
    1119421-2010-00518
    Event Type
    Other
    Date Received
    May 3, 2010
    Date of Event
    January 1, 2010
    Report Date
    April 6, 2010
    Manufacturer
    ALCON RESEARCH, LTD.
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. 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 04/08/2010, 04/12/2010, 04/13/2010, AND 04/16/2010 BY PHONE, FAX, AND MAIL. THE SURGEON WAS UNWILLING TO COMPLETE THE QUESTIONNAIRE. MEDICAL RECORDS WERE RECEIVED ON 04/08/2010. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "UNEXPECTED POSTOPERATIVE REFRACTION" (POSTOPERATIVE REFRACTION, UNEXPECTED). PRODUCT PROBLEM(S): "NONE REPORTED" (NO INFORMATION [IOL (INTRAOCULAR LENS) IMPLANT]). A SURGEON REPORTED A PATIENT WITH AN UNEXPECTED POSTOPERATIVE REFRACTION FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY. MEDICAL RECORDS WERE RECEIVED. ACCORDING TO THE MEDICAL RECORDS, THE PATIENT REPORTED DIFFICULTY READING WITHOUT GLASSES EIGHT DAYS POSTOPERATIVELY. THE PATIENT HAD REQUESTED MONOVISION. THE SURGEON REPORTED IN THE MEDICAL RECORDS "PATIENT LESS MYOPIC THAN SHE HAD HOPED TO BE IN LEFT EYE". THE SURGEON REPORTED THAT ONCE THE REFRACTION WAS STABLE, THEY WOULD CONSIDER THE OPTIONS. ACCORDING TO THE MEDICAL RECORDS, THE PATIENT HAD A HISTORY OF OSTEOPOROSIS, OSTEOARTHRITIS, HYPERTENSION AND HYPERCHOLESTEROLEMIA (PRE-EXISTING). THE SURGEON WAS UNWILLING TO COMPLETE THE QUESTIONNAIRE. THERE ARE THIRTY NINE MEDICAL DEVICE REPORTS ASSOCIATED WITH THESE EVENTS. THIS REPORT IS THIRTY OF THIRTY NINE. THIS IS A BILATERAL EVENT AND THIS REPORT IS FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. SN6AT4 10946807

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other