BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORA SYSTEM 2000

    MDR report key: 7040396 · Received November 17, 2017

    Report

    Report Number
    2028159-2017-04316
    Event Type
    Malfunction
    Date Received
    November 17, 2017
    Report Date
    April 4, 2018
    Manufacturer
    ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER
    Product Code
    NCF
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PROVIDED. THE OPERATORS MANUAL CAUTIONS IT WILL BE DIFFICULT TO OBTAIN ACCURATE, CONSISTENT, AND RELIABLE MEASUREMENTS IF ANY OF THE FOLLOWING CONDITIONS OR SITUATIONS EXISTS: PATIENTS HAVING PROGRESSIVE RETINAL PATHOLOGY SUCH AS DIABETIC RETINOPATHY, MACULAR DEGENERATION, OR ANY OTHER PATHOLOGY THAT THE PHYSICIAN DEEMS WOULD INTERFERE WITH PATIENT FIXATION. PATIENTS HAVING CORNEAL PATHOLOGY SUCH AS FUCHS¿ CORNEAL DYSTROPHY, EPITHELIAL BASEMENT MEMBRANE DYSTROPHY (EBMD), KERATOCONUS, ADVANCED PTERYGIUM IMPAIRING THE CORNEA, OR ANY OTHER PATHOLOGY THAT THE PHYSICIAN DEEMS WOULD INTERFERE WITH THE MEASUREMENT PROCESS. PATIENT¿S FOR WHICH THE PREOPERATIVE REGIMEN INCLUDES RESIDUAL VISCOUS SUBSTANCES LEFT ON THE CORNEAL SURFACE SUCH AS LIDOCAINE GEL OR VISCOELASTICS. VISUALLY SIGNIFICANT MEDIA OPACITY, SUCH AS PROMINENT FLOATERS OR ASTEROID HYALOSIS, WILL LIMIT OR PROHIBIT MEASUREMENT PROCESS. IMAGE QUALITY INDICATOR WILL INDICATE WHEN THIS IS AN ISSUE. PATIENTS HAVING RECEIVED RETRO OR PERIBULBAR BLOCK, OR ANY OTHER TREATMENT THAT IMPAIRS THEIR ABILITY TO VISUALIZE THE FIXATION LIGHT. UTILIZATION OF IRIS HOOKS DURING AN ORA SYSTEM IMAGE CAPTURE WILL YIELD INACCURATE MEASUREMENTS. POTENTIAL COMPLICATIONS INCLUDES: POTENTIAL ERRORS IN MEASURING REFRACTIONS MAY OCCUR WHEN THE CYLINDER, AXIS, OR SPHERICAL EQUIVALENT ARE DISPLAYED IN RED ON THE VERIFEYE SCREEN. SIGNIFICANT CENTRAL CORNEAL IRREGULARITIES RESULTING IN HIGHER ORDER ABERRATIONS MIGHT YIELD INACCURATE REFRACTIVE MEASUREMENTS. POST RK EYES MIGHT YIELD INACCURATE REFRACTIVE MEASUREMENT. THE SYSTEM SERIAL NUMBER (S/N) WAS NOT PROVIDED AND COULD NOT BE DETERMINED BASED ON THE INFORMATION PROVIDED. THEREFORE, MANUFACTURING INFORMATION COULD NOT BE OBTAINED. BASED ON THE INFORMATION PROVIDED FOR THIS INVESTIGATION, THE CUSTOMER REPORTED EVENT IS UNABLE TO BE CONFIRMED. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. 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).

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A DOCTOR REPORTED HIGH LEVELS OF VARIABILITY WITH CYLINDER DURING APHAKIC MEASUREMENTS IN MAGNITUDE COMPARED TO PRE-OPERATIVE PLANS. THE SURGEON DOES NOT FEEL THAT CYLINDER MEASUREMENTS CAN BE RELIED ON AND MAY REQUIRE ASSISTANCE IN ANALYSIS. SYSTEM RECOMMENDATIONS FOR TORIC CASES HAVE NOT BEEN UTILIZED AS A RESULT. THERE HAVE BEEN MULTIPLE OCCURRENCES SINCE THE SYSTEM HAS BEEN COMMISSIONED. NO PATIENT HARM WAS REPORTED. CATARACT EXTRACTION WITH INTRAOCULAR LENS IMPLANT WAS COMPLETED.

    Description of Event or Problem · 1

    UPON FOLLOW UP, IT WAS NOTED THAT THIS OCCURRED WITH TWO PATIENTS. PATIENT NUMBER ONES, GUIDED ANALYZER RECOMMENDATION CONTRADICTED ITSELF BY RECOMMENDING AN INTRAOCULAR LENS (IOL) POWER THAT WAS DIFFERENT AT THE APHAKIC STAGE YET AGREED WITH THE PRE-OPERATIVE CALCULATED IOL POWER IMPLANTED AT THE PSEUDOPHAKIC STAGE. THERE ARE TWO RELATED REPORTS FOR THIS FACILITY. THIS REPORT ADDRESSES PATIENT NUMBER ONE AND ANOTHER MANUFACTURER REPORT WILL BE FILED FOR THE OTHER PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820322 ORA SYSTEM 2000 ABERROMETER, OPHTHALMIC NCF ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other