BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 2403804 · Received January 5, 2012

    Report

    Report Number
    3008772169-2012-00002
    Event Type
    Injury
    Date Received
    January 5, 2012
    Date of Event
    December 6, 2011
    Report Date
    December 6, 2011
    Manufacturer
    ALCON - LENSX LASERS, INC.
    Product Code
    OOE
    PMA / PMN Number
    K101626
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE OCT IMAGE WAS REPORTED TO BE INTERMITTENTLY GRAINY, THIS IS NOT RELATED TO THE ADVERSE EVENT, AS THE SURGEON WAS ABLE TO VISUALIZE THE ALL OF THE OCULAR STRUCTURES. A COMPANY SERVICE REPRESENTATIVE WAS DISPATCHED TO ADDRESS THE OCT IMAGE ISSUE AND FOUND THE DEVICE WAS WITHIN SPECIFICATIONS. THE CAUSE OF THE POSTERIOR CAPSULE TEAR IS UNK, HOWEVER CAPSULAR TEARS ARE AN INHERENT RISK OF CATARACT SURGERY. (B)(4).

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT UPON COMPLETING NUCLEUS REMOVAL, THERE WAS A VISIBLE BUBBLE BEHIND THE REMAINING QUADRANT. UPON ENGAGING THE FINAL QUADRANT WITH THE PHACO HANDPIECE THE BUBBLE DISAPPEARED, FOLLOWED BY AN OPENING IN THE POSTERIOR CAPSULE AND SUBSEQUENT DROP IN THE REMAINING NUCLEAR FRAGMENT. THE PT WAS REFERRED TO A RETINAL SPECIALIST. ADDITIONAL INFORMATION WAS PROVIDED BY THE SURGEON, WHO REPORTED THAT ON THE DATE OF THIS PROCEDURE THE OCT PERFORMANCE WAS VARIABLE, BUT HE WAS ABLE TO MAKE OUT ALL OF THE STRUCTURES. THE LASER CASE WAS NORMAL AND THE OPERATING ROOM CASE PROCEEDED NORMALLY INCLUDING CAPSULOTOMY AND HYDRODISSECTION UP TO THE END OF THE PHACO PROCESS. PRIOR TO REMOVING THE LAST PIECE OF THE NUCLEUS, THE SURGEON REPORTED LOSING THE LAST PIECE INTO THE VITREOUS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK