BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 772574 · Received October 20, 2006

    Report

    Report Number
    1119421-2006-00354
    Event Type
    Other
    Date Received
    October 20, 2006
    Date of Event
    March 22, 2006
    Report Date
    September 22, 2006
    Manufacturer
    ALCON LABORATORIES, INC. / HUNTINGTON
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT HAS NOT BEEN RECEIVED FOR EVALUATION. THE DEVICE REMAINS IMPLANTED. PRODUCT HISTORY RECORDS WERE REVIEWED AND ALL DOCUMENTS INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS RECEIVED FOR THIS LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED BY FAX AND MAIL ON 09/22/2006. TELEPHONE FOLLOW-UP WAS CONDUCTED ON 10/05/2006. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 10/06/2006.

    Description of Event or Problem · 1

    A PATIENT REPORTS, SHE IS UNHAPPY WITH HER OUTCOME FOLLOWING UNILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY. SHE REPORTED PROBLEMS WITH BLURRED NEAR VISION. SHE STATED, THE SURGEON TOLD HER THE IOL WAS CROOKED. DURING THE CONVERSATION, SHE MENTIONED THAT SHE HAS A HISTORY OF FUCH'S DYSTROPHY AND HAD A RETINAL TEAR REPAIRED FOLLOWING HER SURGERY. DURING TELEPHONE FOLLOW-UP WITH THE SURGEON, HE CONFIRMED THE LENS WAS SLIGHTLY DISPLACED SUPERIORLY, BUT THAT HE DID NOT WANT TO INTERVENE DUE TO THE FUCH'S DYSTROPHY AND A FAMILY HISTORY OF RETINITIS PIGMENTOSA. ALTHOUGH EXTENSIVE PREOPERATIVE EDUCATION WAS PROVIDED REGARDING THE FUCH'S DYSTROPHY CAUSING INCREASED CORNEAL EDEMA, DELAYED CLEARING OF VISION AND FLUCTUATING VISION, THE SURGEON NOW FEELS HE SHOULD HAVE DISQUALIFIED THIS PATIENT FROM HAVING THIS LENS MODEL IMPLANTED DUE TO UNREALISTIC EXPECTATIONS. THE SURGEON DOES NOT HAVE ANY PLANS TO INTERVENE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON LABORATORIES, INC. / HUNTINGTON SN60D3 923974

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other