BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCURUS 800CS

    MDR report key: 2945002 · Received February 4, 2013

    Report

    Report Number
    2028159-2013-00177
    Event Type
    Injury
    Date Received
    February 4, 2013
    Report Date
    January 5, 2013
    Manufacturer
    ALCON- IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K911808
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A LITERATURE ARTICLE REPORTED THAT THEIR SYSTEM WAS USED FOR A CATARACT PROCEDURE IN WHICH RETAINED LENS MATERIAL WAS NOTED IN THE POSTERIOR SEGMENT FOLLOWING THE PROCEDURE. THE LENS MATERIAL WAS REMOVED VIA A PARS PLANA VITRECTOMY USING A PHACOEMULSIFICATION HANDPIECE. THE CUSTOMER REPORTED THE PATIENT DEVELOPED EPIRETINAL MEMBRANE (ERM) AND CYSTOIDS MACULAR EDEMA (CME). A COMPANY CLINICAL ANALYST REVIEWED THIS FILE AND STATED THE FOLLOWING: IN THE LITERATURE ARTICLE, THE AUTHORS DESCRIBE REMOVAL OF RETAINED LENS MATERIAL VIA TRADITIONAL FRAGMATOME OR WITH A PHACO HANDPIECE, IN THE POSTERIOR CHAMBER THROUGH A PARS PLANA APPROACH (OFF LABEL USE). TWO EYES IN THE TORSIONAL ULTRASOUND GROUP AND THREE EYES IN THE FRAGMATOME GROUP DEVELOPED CME. THIS WOULD BE EXPECTED IN EYES WITH RLM. IN THIS STUDY, NONE OF THE OBSERVED COMPLICATIONS COULD BE DEFINITIVELY LINKED TO PHACOFRAGMENTATION. ACCORDING TO THE AUTHOR, THE PHACO EQUIPMENT IS NOT LINKED WITH THE REPORTED POSTOPERATIVE OCCURRENCES OF CME. IN THE INTRODUCTORY PARAGRAPH OF THE MANUSCRIPT, THE AUTHOR CLEARLY STATES THE FOLLOWING: RETAINED LENS MATERIAL (RLM) IS A RARE COMPLICATION OF CATARACT SURGERY, OCCURRING IN 0.1% TO 1.5% OF PATIENTS (1-5) AND MAY ALSO OCCUR AFTER OCULAR TRAUMA. CERTAIN FACTORS INCREASE THE RISK FOR THE DEVELOPMENT OF RLM, INCLUDING PSEUDOEXFOLIATIVE SYNDROME, PREVIOUS TRAUMA OF INTRAOCULAR SURGERY, INCREASING LENS DENSITY, AND LESS SURGEON EXPERIENCE. ACCORDING TO THE AUTHOR, SURGICAL EQUIPMENT IS NOT INCLUDED IN FACTORS CONTRIBUTING TO RLM. THERE WAS NO SAMPLE RETURNED FOR EVALUATION AND NO ADDITIONAL INFORMATION PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. THE ROOT COULD NOT BE DETERMINED CONCLUSIVELY; HOWEVER IT IS NOT RELATED TO USE OF THE SYSTEM. (B)(4).

    Description of Event or Problem · 1

    IN A LITERATURE REPORT WRITTEN ON A COMPARISON OF DEVICES TO REMOVE RETAINED LENS MATERIAL, 34 PATIENTS WERE IDENTIFIED AS HAVING REQUIRED PARS PLANA VITRECTOMY PROCEDURES TO REMOVE LENS MATERIAL FOLLOWING COMPLICATED CATARACT SURGERY OR TRAUMATIC/SPONTANEOUS LENS DISLOCATION. THIS REPORT REPRESENTS ONE IDENTIFIED PATIENT THAT DEVELOPED AN EPIRETINAL MEMBRANE AND CYSTOID MACULAR EDEMA FOLLOWING THE REMOVAL OF THE LENS MATERIAL. AS A RESULT, AN ADDITIONAL PARS PLANA VITRECTOMY PROCEDURE WAS PERFORMED. THE PATIENT WAS LEFT APHAKIC. THIS IS THE SECOND OF TWO REPORTS BEING FILED FOR THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45846 ACCURUS 800CS PHACOFRAGMENTATION SYSTEM HQC ALCON- IRVINE TECHNOLOGY CENTER ACCURUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention FRAGMATOME