BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTURION VISION SYSTEM

    MDR report key: 4792189 · Received May 22, 2015

    Report

    Report Number
    2028159-2015-06124
    Event Type
    Injury
    Date Received
    May 22, 2015
    Report Date
    September 8, 2015
    Manufacturer
    ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K121555
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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 ADDITION REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS EXAMINED. THE COMPANY REPRESENTATIVE DID NOT INDICATE FINDING ANY ISSUES THAT WOULD BE ASSOCIATED WITH THE REPORTED EVENT. A REVIEW OF THE CUSTOMER¿S COMPLAINT HISTORY FOR THE LAST 24 MONTHS DID NOT SHOW ANY PREVIOUS COMPLAINTS OF THIS KIND AGAINST THE SYSTEM. THE SYSTEM WAS MANUFACTURED ON MARCH 5, 2014. BASED ON QA ASSESSMENT AND A REVIEW OF THE MANUFACTURING RECORD, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE SYSTEM WAS FOUND TO MEET SPECIFICATIONS. THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED CONCLUSIVELY. POSTERIOR CAPSULE (PC) TEAR IS A POTENTIAL CONSEQUENCE OF CATARACT EXTRACTION BY PHACOEMULSIFICATION. PREDISPOSITION TO PC TEAR OR ZONULAR DEHISCENCE CAN BE INFLUENCED BY MANY FACTORS INCLUDING, BUT NOT LIMITED TO, CONGENITAL POSTERIOR LENTICONUS, POSTERIOR SUB CAPSULAR (PSC) CATARACT, POOR VISIBILITY SECONDARY TO PATIENTS COMORBIDITY [IE. DENSE ARCUS, PTERYGIUM, BAND KERATOPATHY, CORNEAL SCARS, INTERSTITIAL KERATITIS], POOR MICROSCOPE ILLUMINATION [RED REFLEX], ERGONOMIC OBSTACLES, LIMITED INTRAOCULAR WORKING SPACE, ABNORMALLY LONG OR SHORT AXIAL LENGTHS, PSEUDOEXFOLIATION, ZONULAR LAXITY, POOR DILATION, INTRAOPERATIVE FLOPPY IRIS SYNDROME (IFIS), DENSE CATARACTS, ASTEROID HYALOSIS, OR INADVERTENT PATIENT MOVEMENT. THE CONDITIONS THAT INCREASE THE RISK OF PC TEAR DURING PHACOEMULSIFICATION INCLUDE ERGONOMIC OBSTACLES, LIMITED INTRAOCULAR WORKING SPACE, POOR VISUALIZATION, INCREASED NUCLEAR SIZE AND DENSITY, WEAKENED ZONULE, A RADIAL TEAR IN THE CAPSULORHEXIS, AND AN INABILITY TO ROTATE THE NUCLEUS OR EPINUCLEUS. THESE CONDITIONS MAY ARISE EITHER BECAUSE OF THE OCULAR ANATOMY, OR BECAUSE OF SURGICAL TECHNIQUE. THERE IS NO EVIDENCE CONTAINED WITHIN THE REPORTED INFORMATION AT THIS TIME THAT INDICATES THAT THE DESIGN OR PERFORMANCE OF THE SYSTEM HAD ANY EFFECT ON THE INTEGRITY OF THE POSTERIOR CAPSULE. POSTERIOR CAPSULE TEAR IS AN ISSUE THAT IS OCCASIONALLY REPORTED WITH CATARACT SURGERY. HOWEVER, A REVIEW OF THE COMPLAINT TRENDS SHOWS THAT THE FREQUENCY REPORTED IS WITHIN KNOWN LEVELS FOR THIS EVENT. A ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A DOCTOR REPORTED EXPERIENCING POOR PHACOMULSIFICATION DURING A PROCEDURE. THE CASE RESULTED IN A POSTERIOR CAPSULAR TEAR. THE CASE WAS COMPLETED. THE PHYSICIAN INDICATED THE INCIDENT OCCURRED DUE TO A VERY HARD LENS AND POOR PHACOMULSIFICATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336752 CENTURION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other