BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1963347 · Received January 14, 2011

    Report

    Report Number
    9612169-2011-00003
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 15, 2010
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; HOWEVER, TWO PHOTOGRAPHS WERE RETURNED AND ASSESSED. IT APPEARED THAT THE PHOTOS WERE TAKEN UNDER SLIT LAMP EXAMINATION WHILE STILL IMPLANTED IN THE PT'S EYE. THE LENS APPEARED TO HAVE AN OPAQUE REGION ON THE OPTIC SURFACE; HOWEVER, NO DETERMINATION COULD BE MADE FROM THE PHOTOS. WE WERE UNABLE TO CONFIRM PRODUCT DAMAGE WITHOUT EVAL OF THE PHYSICAL SAMPLE. RESULTS FROM THE PRODUCT AND BATCH HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE: THE ROOT CAUSE FOR THE REPORTED COMPLAINT COULD NOT BE DETERMINED AS NO PRODUCT WAS RETURNED FOR ANALYSIS. NO DETERMINATION COULD BE MADE FROM THE PHOTOGRAPHS PROVIDED BY THE CUSTOMER. BASED ON THE RESULTS FROM THE PRODUCT AND BATCH HISTORY RECORD, THE PRODUCT MET RELEASE CRITERIA. ACTIONS: THERE HAVE BEEN NO OTHER SIMILAR COMPLAINTS FOR THIS LOT. NO FURTHER ACTION IS WARRANTED AT THIS TIME. ADDITIONAL INFO WAS REQUESTED AND RECEIVED. NO FURTHER INFO IS EXPECTED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT TWO DAYS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, UPON LENS EXAMINATION HE OBSERVED CLOUDING/DEPOSITS ON THE IOL. IN A F/U, THE SURGEON REPORTED HE WAS ABLE TO ASPIRATE/WASH OFF THE STICKY COATING ON THE FRONT SURFACE OF THE IOL. THE ETIOLOGY OF THE EVENT IS UNCLEAR (UNK). NO FURTHER INFO IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SN60WF 21017830

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention