BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2546583 · Received April 20, 2012

    Report

    Report Number
    1119421-2012-00537
    Event Type
    Injury
    Date Received
    April 20, 2012
    Date of Event
    October 1, 2011
    Report Date
    March 22, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: LENS WAS RETURNED IN A NON-ALCON LENS CASE THAT APPEARS TO INDICATE A 21.0 DIOPTER LABEL. THE LENS HAS SOLUTION, BROKEN HAPTICS AND MULTIPLE AREAS OF OPTIC DAMAGE. A LENS BENCH TEST WAS ATTEMPTED ON THE DAMAGED RETURNED LENS. THE DIOPTER WAS INDICATED TO BE WITHIN THE RANGE FOR AN 22.5 DIOPTER LENS. PRODUCT HISTORY RECORD REVIEW INDICATED THE LENS MET RELEASE CRITERIA. THE ROOT CAUSE OF THE LENS DAMAGE CANNOT BE DETERMINED FROM THE PRODUCT INVESTIGATION. WHILE WE ARE UNABLE TO DETERMINE THE ORIGIN OF THE DAMAGE, OUR OBSERVATION REASONABLY SUGGESTS THAT IT IS NOT MANUFACTURING RELATED. DUE TO THE PRESENCE OF THE SURGICAL SOLUTION, THE DAMAGE IS MOST LIKELY CUSTOMER RELATED. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 03/23/2012 AND 04/04/2012 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 04/04/2012. (B)(4).

    Description of Event or Problem · 1

    A TECHNICIAN REPORTED THAT, FOR BOTH EYES, THE INTRAOCULAR LENSES (IOLS) WERE EXCHANGED DUE TO MECHANICAL FAILURE. IN A FOLLOW-UP, THE TECHNICIAN REPORTED THAT, WHILE THE PATIENT'S VISUAL ACUITY WAS GOOD, SHE WAS UNABLE TO TOLERATE THE INITIAL LENSES DUE TO GLARE AND GHOSTING OF LETTERS WHEN READING. SHE ALSO CLARIFIED THAT "MECHANICAL FAILURE" WAS NOT A QUALITY ISSUE OF THE LENS, RATHER IT IS IN REFERENCE TO THE PATIENT'S INTOLERANCE WITH THE GHOSTING. SHE REPORTED THE LENSES WERE EXCHANGED FOR MONOFOCAL LENSES AND THE EVENT HAS RESOLVED. ADDITIONAL INFORMATION FROM THE NURSE INDICATED THAT AN UNAPPROVED VISCOELASTIC WAS USED DURING THE SURGERY. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN6AD1 12048667

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention HEALON| MONARCH CARTRIDGE D| MONARCH HANDPIECE III