BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 2372928 · Received December 8, 2011

    Report

    Report Number
    3008772169-2011-00006
    Event Type
    Injury
    Date Received
    December 8, 2011
    Date of Event
    November 9, 2011
    Report Date
    November 9, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY REPRESENTATIVE WAS DISPATCHED TO INVESTIGATE AND SERVICE THE DEVICE. DURING THE SERVICE VISIT, THE ENGINEER FOUND THAT THE DEVICE WAS OUT OF SPECIFICATION AND REQUIRED ALIGNMENT OF THE LASER. THIS FINDING HAS THE POTENTIAL TO CAUSE DECREASED PHOTODISRUPTION IN THE CAPSULOTOMY PATTERN, HOWEVER THIS FINDING WILL NOT AFFECT THE LASER'S TREATMENT DEPTH OR POSITION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS THAT RELATE TO THE REPORTED ISSUE. CONCLUSIONS: ROOT CAUSE OF THE POSTERIOR CAPSULE TEAR CANNOT BE DETERMINED. ALTHOUGH THE DEVICE WAS OUT OF ALIGNMENT AND SUBSEQUENTLY RESULTED IN AN INCOMPLETE CAPSULOTOMY PATTERN AND ANTERIOR CAPSULE TEAR, IT CANNOT BE CONCLUDED THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE POSTERIOR CAPSULE TEAR., WHICH WAS NOT LOCATED IN THE SAME AREA AND WAS NOT NOTED UNTIL AFTER THE ENTIRE LENS WAS REMOVED AND THE INTRAOCULAR LENS WAS BEING INSERTED. POSTERIOR CAPSULE TEARS MOST COMMONLY OCCUR DURING PHACOEMULSIFICATION OR IRRIGATION/ASPIRATION STEPS. IN ADDITION, IT CANNOT BE CONCLUDED THAT THE DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE ANTERIOR CAPSULE TEAR, BECAUSE THE CAPSULOTOMY INCISION IS UNDER THE PURVIEW OF THE SURGEON'S CAPSULORRHEXIS SURGICAL MANEUVERS. CAPSULAR TEARS (BOTH ANTERIOR AND POSTERIOR) ARE AN INHERENT RISK OF CATARACT SURGERY. REFERENCES: MARQUES FF, MARQUES DMV, OSHER RH, OSHER JM. FATE OF ANTERIOR CAPSULE TEARS DURING CATARACT SURGERY. J CATARACT REFRACT SURG 2006; 32:1638-1642. GIMBEL HV, SUN, R, FERENSOWICZ M, PENNO EA, ET AL. INTRAOPERATIVE MANAGEMENT OF POSTERIOR CAPSULE TEARS IN PHACOEMULSIFICATION AND INTRAOCULAR LENS IMPLANTATION. OPHTHALMOLOGY 2001; 108: 2186-92. (B)(4).

    Description of Event or Problem · 1

    THE SURGEON REPORTED A CASE WHERE AN "INCOMPLETE ANTERIOR CAPSULORRHEXIS AND PARTIAL POSTERIOR CAPSULORRHEXIS WAS CREATED." THE SURGEON STATED THAT DURING THE PLACEMENT OF THE CONTROL POINTS HE MOVED THE LENS TREATMENT SLIGHTLY MORE ANTERIOR AND SLIGHTLY MORE POSTERIOR THAN THE PRE-PLACED POSITION. HOWEVER, THAT DURING THE LASER TREATMENT IT LOOKED LIKE THE LASER SKIPPED AREAS. ONCE HE MOVED THE PATIENT INTO THE OPERATING ROOM, ALL OF THE INCISIONS SEEMED DIFFICULT TO OPEN, SEEMED THE DEPTH WAS OFF, AND REPORTED THE LENS TO BE SOFT. THE CAPSULOTOMY PATTERN WAS INCOMPLETE FROM 10:00-12:00 WITH AN ANTERIOR CAPSULAR EXTENSION, WHICH WAS NOT AN ISSUE. AS THE SURGEON WAS INSERTING THE INTRAOCULAR LENS, HE RECOGNIZED A POSTERIOR CAPSULAR TEAR FROM 6:00 - 10:00. HE IS NOT SURE IF THE TEAR OCCURRED DURING HYDRODISSECTION, PHACO OR POLISH "IT IS HARD TO BELIEVE THE LASER WOULD HAVE CAUSED THE TEAR, HOWEVER, IT WAS SO SYMMETRICALLY ROUND IN NATURE THAT IT LOOKS LIKE IT COULD HAVE BEEN LASER INDUCED." THE PATIENT DID WELL WITH NO ADVERSE AFFECTS AND VITRECTOMY WAS NOT REQUIRED.

    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 52 YR Required Intervention