BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1642773 · Received March 25, 2010

    Report

    Report Number
    1119421-2010-00346
    Event Type
    Other
    Date Received
    March 25, 2010
    Date of Event
    February 1, 2010
    Report Date
    February 23, 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
    TX, US
    Reporter Occupation
    OTHER

    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 03/01/0201, 03/04/2010, 03/08/2010, AND 03/12/2010 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. MEDICAL RECORDS WERE RECEIVED ON 03/19/2010. (B) (4). (B) (4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "HYPEROPIC SURPRISE" (POSTOPERATIVE REFRACTION, UNEXPECTED); "EXPERIENCING IRRITATION" (IRRITATION); "EXPERIENCING FOREIGN BODY SENSATION" (FOREIGN BODY SENSATION) PRODUCT PROBLEM(S): "NONE REPORTED" (NO INFORMATION [IOL (INTRAOCULAR LENS IMPLANTED]). A SURGEON REPORTED A PATIENT WITH A HYPEROPIC SURPRISE FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. MEDICAL RECORDS WERE RECEIVED. ACCORDING TO THE MEDICAL RECORDS, THE PATIENT HAD NARROW ANGLE GLAUCOMA WHICH WAS BEING TREATED WITH MEDICATIONS (PRE-EXISTING). A LASER IRIDOTOMY WAS PERFORMED ON THE RIGHT EYE ON (B) (6) 2010. THE PATIENT WAS ALSO DIABETIC (PRE-EXISTING). FOLLOWING THE IOL IMPLANT PROCEDURE, THE PATIENT WAS EXPERIENCING FOREIGN BODY SENSATION AND IRRITATION ON 02/11/2010; ON THIS DATE, A SUTURE WAS REMOVED. THE PATIENT CONTINUED TO EXPERIENCE BLURRY VISION. ON (B) (6) 2010, THE PATIENT WAS FITTED FOR CONTACT LENSES. SHE WAS ALSO REFERRED FOR A RETINAL CONSULTATION BECAUSE THE SURGEON COULD FIND NO OBVIOUS CAUSE FOR HER VISION NOT IMPROVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60AT 10923865

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other AZOPT| PILOCARPINE