BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 2471909 · Received February 27, 2012

    Report

    Report Number
    3008772169-2012-00005
    Event Type
    Injury
    Date Received
    February 27, 2012
    Date of Event
    January 31, 2012
    Report Date
    January 31, 2012
    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
    CI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SERVICE ENGINEER WAS ONSITE AT THE TIME OF THE EVENT AND EVALUATED THE LASER SYSTEM, WHICH WAS FOUND TO BE WITHIN SPECIFICATIONS AND NO DEVICE MALFUNCTION OCCURRED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO UNUSUAL FINDINGS RELATED TO THE REPORTED INCIDENT. CAPSULAR TEARS AND ANTERIOR CHAMBER COLLAPSE ARE INHERENT RISKS OF CATARACT SURGERY. A MEDICAL SAFETY PHYSICIAN REVIEWED THE CASE AND CONCLUDED THAT THE LIKELY ROOT CAUSE OF THE ADVERSE EVENT IS RELATED TO THE SURGEON'S INADVERTENT OPENING OF THE PRIMARY INCISION WITHOUT STABILIZING THE ANTERIOR CHAMBER FIRST WITH VISCOELASTIC, WHICH CAUSED THE ANTERIOR CHAMBER TO COLLAPSE AND CONSEQUENTLY RESULTED IN A CAPSULAR TEAR. INJECTION OF VISCOELASTIC IS STANDARD PRACTICE/TRAINING. (B)(4).

    Description of Event or Problem · 1

    A COMPANY REPRESENTATIVE WAS OBSERVING SURGERY AND REPORTED THAT A PT PRESENTED WITH A TEAR AT THE CAPSULE DURING IRRIGATION/ASPIRATION, AT THE EPINUCLEUS ASPIRATION. WHEN THE SURGEON PERFORMED THE CAPSULOTOMY AND REMOVED THE NUCLEUS, ALL SEEMED TO BE OKAY. AFTER THIS, WE REVIEWED THE SURGICAL VIDEO AND NOTICED THAT AFTER OPENING THE SECONDARY INCISION, THE SURGEON DID NOT USE OVD (VISCOELASTIC) BEFORE OPENING THE PRIMARY INCISION. AS SOON AS THE SURGEON OPENED THE PRIMARY INCISION, THE ANTERIOR CHAMBER COLLAPSED, AND WE WERE ABLE TO APPRECIATE TRACTION IN THE CAPSULE AT THE SAME ZONE WHERE THE TEAR OCCURRED. THE SURGEON WAS ABLE TO FINISH SURGERY WITHOUT ANY PROBLEM AND ALSO USED THE SAME IOL THAT HE HAD PLANNED TO USE. THE COMPANY REPRESENTATIVE FOLLOWED UP WITH THE SURGEON AND THE PT IS DOING OKAY ONE DAY POSTOPERATIVELY.

    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 71 YR Required Intervention