BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2525123 · Received April 4, 2012

    Report

    Report Number
    1119421-2012-00464
    Event Type
    Injury
    Date Received
    April 4, 2012
    Date of Event
    July 1, 2011
    Report Date
    March 8, 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

    EVAL SUMMARY: THE PRODUCT WAS RETURNED FOR EVAL. OPTIC AND HAPTIC DAMAGE WAS OBSERVED. SOLUTION IS DRIED ON THE LENS. PRODUCT HISTORY AND BATCH RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. THE ROOT CAUSE COULD NOT BE DETERMINED FOR THE REPORTED COMPLAINT OF MECHANICAL FAILURE AS THE EXACT NATURE OF THE COMPLAINT IS UNK. THE RESOLUTION AND FOCAL LENGTH WERE ACCEPTABLE. LENS DAMAGE WAS OBSERVED. WHILE WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE DAMAGE, OUR OBSERVATION REASONABLY SUGGESTS THAT IT IS NOT MFG RELATED. DUE TO THE PRESENCE OF SURGICAL SOLUTION, THE DAMAGE IS MOST LIKELY RELATED TO CUSTOMER HANDLING. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED ON 03/13/2012 AND 03/22/2012 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 03/22/2012. (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMIC ASSISTANT REPORTED AN INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO "MECHANICAL FAILURE." IN A F/U, THE OPHTHALMIC ASSISTANT REPORTED THAT ALTHOUGH THE VISION WAS GOOD, THE LENS WAS EXCHANGED DUE TO THE PT HAVING TOO MUCH DIFFICULTY WITH RINGS AROUND LIGHTS AT NIGHT. SHE ALSO INDICATED THAT POSTERIOR CAPSULE OPACIFICATION WAS NOTED TWO MONTHS AFTER THE INITIAL IMPLANT SURGERY. THE OPHTHALMIC ASSISTANT REPORTED THE EVENT RESOLVED WITH TREATMENT (EXCHANGE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AD1 12012957

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention HEALON| MONARCH DELIVERY SYSTEM