BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 3925447 · Received June 18, 2014

    Report

    Report Number
    1119421-2014-00465
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 20, 2014
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED SUBMERGED IN A TUBE OF CLEAR LIQUID. PRODUCT WAS ALLOWED TO COMPLETELY AIR DRY AND THEN EVALUATED. PATTERNS OF DRIED SOLUTION, HAPTIC DAMAGE AND OPTIC DAMAGE WERE OBSERVED. MULTIPLE SPOTS OF YAG LASER DAMAGED AREAS WERE ALSO OBSERVED IN THE OPTIC. ADDITIONAL TESTING OF THE OPTIC SHOWED ACCEPTABLE RESULTS PER PLAN VIEW TEMPLATE, PER FOLD TESTING, AND WITH THE OPTICAL RESOLUTION. A DEFINITIVE DIOPTER READING COULD NOT BE OBTAINED DUE TO THE PRESENCE OF THE DAMAGED OPTIC MATERIAL. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE FOR THE COMPLAINT OF EYESIGHT WORSE IN A PT WHO RECEIVED THE IOL TEN YEARS PRIOR. A SPECIFIC ALLEGED MALFUNCTION AGAINST THE LENS WAS NOT INDICATED BY THE CUSTOMER. THE OPTIC SHOWED ACCEPTABLE RESULTS PER PLAN VIEW TEMPLATE, ACCEPTABLE FOLD TESTING, AND ACCEPTABLE OPTIC RESOLUTION. THE FILE ALSO INDICATED THAT IT IS UNK IF SSNG OR A COMPLICATION WAS THE POSSIBLE CAUSE OF THE COMPLAINT. THE PHENOMENON DESCRIBED AS SSNG MAY OCCUR AS A RESULT OF SUBJECTING THE LENS TO SIGNIFICANT TEMPERATURE VARIATIONS. THE REMOVAL OF THE LENS FROM THE EYE TO A COLD SURGICAL SUITE ATMOSPHERE COULD CAUSE THIS PHENOMENON. THE PHENOMENON DISSIPATED ONCE THE LENS WAS ALLOWED TO AIR DRY AND ACCLIMATE. THE RETURNED LENS HAD HAPTIC DAMAGE, CRACKED OPTIC AND YAG LASER DAMAGED AREAS IN THE OPTIC. THE CRACKED OPTIC AND THE HAPTIC DAMAGE WERE TYPICAL IN APPEARANCE TO HANDLING RELATED DAMAGE. WHILE WE ARE UNABLE TO DETERMINE THE EXACT ORIGIN OF THE HAPTIC AND SPLIT/CRACKED OPTIC DAMAGE, OUR OBSERVATION REASONABLY SUGGESTS THAT IT IS NOT MANUFACTURING RELATED. THE STARBURST PATTERNS IN THE OPTIC ARE SIMILAR IN APPEARANCE TO DAMAGE FROM YAG LASER TREATMENT. THE SURGEON WAS UNWILLING TO PROVIDE FURTHER INFO. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT TEN YEARS AFTER AN INTRAOCULAR LENS (IOL) WAS IMPLANTED. THE PT REPORTED A DECREASE IN VISION. THE IOL WAS EXCHANGED. ADDITIONAL INFO WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356748 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON MA50BM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention