BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 4890549 · Received July 6, 2015

    Report

    Report Number
    3008772169-2015-00612
    Event Type
    Injury
    Date Received
    July 6, 2015
    Date of Event
    June 8, 2015
    Report Date
    September 21, 2015
    Manufacturer
    ALCON LENSX, INC.
    Product Code
    OOE
    PMA / PMN Number
    K101626
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: A COMPANY REPRESENTATIVE REVIEWED THE PROVIDED SYSTEM IMAGES OF THE OPTICAL COHERENCE TOMOGRAPHY (OCT) SCANS AND THE INCISION OVERLAYS FOR THE TREATMENT OF THE REPORTED EVENT. A REVIEW OF THE IMAGES DID NOT REVEAL ANY ATYPICAL TREATMENT SETTINGS THAT COULD HAVE CONTRIBUTED TO THE EVENT. NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED. WITH NO ADDITIONAL, RELATED INFORMATION PROVIDED, THE CUSTOMERS REPORTED EVENT WAS NOT ABLE TO BE CONFIRMED. THE SYSTEM MET SPECIFICATIONS AT THE TIME OF RELEASE THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY.

    Description of Event or Problem · 1

    A DOCTOR OF OPHTHALMOLOGY REPORTED CAPSULE TEAR NOTICED DURING THE CLEANING OF THE LAST PART OF THE CAPSULE DURING A CATARACT SURGERY. THERE WAS NO PROBLEM DURING THE LASER SURGERY. THE LENS WAS IMPLANTED INTO THE EYE AND SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435907 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other