BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 5070508 · Received September 11, 2015

    Report

    Report Number
    3008772169-2015-00708
    Event Type
    Injury
    Date Received
    September 11, 2015
    Date of Event
    August 17, 2015
    Report Date
    January 8, 2016
    Manufacturer
    ALCON LENSX, INC.
    Product Code
    OOE
    PMA / PMN Number
    K101626
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED TO A COMPANY REPRESENTATIVE A PATIENT WITH AN ANTERIOR CAPSULAR TEAR REQUIRING A VITRECTOMY DURING LASER ASSISTED CATARACT SURGERY. THE LASER AND SURGICAL PORTIONS PROCEEDED WITHOUT ISSUE; ONCE THE CATARACT WAS EXTRACTED THE SURGEON REMOVED THE INSTRUMENTS FROM THE EYE AND NOTED THAT EVERYTHING CAME FORWARD WITH A BIG TRAMPOLINE EFFECT; SHE ADDITIONALLY INDICATED THAT VISCOELASTICS WERE NOT USED AS THEY NORMALLY WOULD HAVE BEEN. UPON BEGINNING THE IRRIGATION AND ASPIRATION SHE NOTED AN ANTERIOR TEAR THAT WENT TO THE BACK OF THE BAG AND EXTENDED TO THE SIDE. AN ANTERIOR VITRECTOMY WAS PERFORMED AND A SULCUS INTRAOCULAR LENS WAS IMPLANTED. ACETYLCHOLINE OPHTHALMIC SOLUTION WAS USED TO CONSTRICT THE PUPIL FOLLOWED BY A SUTURE TO CLOSE THE EYE. THE SURGEON REPORTS NO ANTERIOR TEARS WHEN PERFORMING MANUAL CAPSULOTOMIES VERSUS THE LASER ASSISTED CAPSULOTOMIES. UPON ADDITIONAL FOLLOW UP IT WAS REPORTED THAT THE PATIENT IS DOING WELL WITHOUT FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601452 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX, INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other