BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 4973360 · Received August 5, 2015

    Report

    Report Number
    2028159-2015-07486
    Event Type
    Injury
    Date Received
    August 5, 2015
    Date of Event
    July 9, 2015
    Report Date
    October 8, 2015
    Manufacturer
    ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K120912
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: CORNEAL THERMAL INJURIES ARE TYPICALLY RELATED TO EXCESSIVE HEAT GENERATED BY THE PHACO TIP DUE TO INSUFFICIENT ASPIRATION FLOW, EXTENDED ENERGY APPLICATION, OR COMBINATION OF BOTH. THE SYSTEM IS DESIGNED TO COOL THE PHACO TIP DURING USE AS ASPIRATED FLUID FLOWS THROUGH THE TIP LUMEN. OVERHEATING OF THE PHACO TIP, HOWEVER, MAY OCCUR DUE TO EXTENDED APPLICATION OF ULTRASONIC ENERGY OR COMPROMISED ASPIRATION FLOW THROUGH THE PHACO TIP. REDUCED FLUID FLOW THROUGH THE PHACO TIP MAY BE CAUSED BY PHACO TIP RE-USE, TIP CLOGGING BY NUCLEAR MATERIAL, KINKED TUBING, INADEQUATE FLOW AND VACUUM SETTINGS, OR OBSTRUCTION BY OPHTHALMIC VISCOELASTIC DEVICE (OVD). WHEN THE PHACO TIP IS OCCLUDED, INFUSION WILL CEASE, REDUCING THE COOLING EFFECT OF THE TIP. OCCLUSION TONES (INTERMITTENT BEEPING TONES DURING OCCLUSION) ALERT THE USER, INDICATING THAT THE VACUUM IS NEAR OR AT ITS PRESET LIMIT, AND ASPIRATION FLOW IS REDUCED OR STOPPED. THE SURGEON MUST RECOGNIZE THE OCCLUSION TONES AND MANUALLY STOP THE ULTRASOUND MODE IN ORDER TO PREVENT A RAPID TEMPERATURE INCREASE. THE SYSTEM WAS EXAMINED AND THE REPORTED EVENT WAS NOT REPLICATED. THE SYSTEM WAS TESTED AND FOUND TO MEET PRODUCT SPECIFICATIONS. A COMPANY REPRESENTATIVE NOTED THE PHACO HANDPIECE HAS BEEN USED MULTIPLE TIMES WITH NO FURTHER EVENTS. THE SYSTEM MET SPECIFICATIONS AT THE TIME OF RELEASE. FOR THIS OZIL TORSIONAL PHACO HANDPIECE, THE SERIAL NUMBER (S/N) WAS NOT PROVIDED AND COULD NOT BE DETERMINED BASED ON THE INFORMATION PROVIDED. THEREFORE, MANUFACTURING INFORMATION COULD NOT BE OBTAINED. CORNEAL BURN IS AN ISSUE THAT IS OCCASIONALLY REPORTED WITH CATARACT SURGERY. ACCORDING TO THE PENNSYLVANIA PATIENT SAFETY ADVISORY ABSTRACT: PREVENTING CORNEAL BURNS DURING PHACOEMULSIFICATION, MARCH 2010, VOL. 7, NO. 1: 23-25, MOST CORNEAL BURNS CAN BE TRACED TO ISSUES RELATED TO SURGICAL TECHNIQUE AND NOT TO MALFUNCTIONING EQUIPMENT. A ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    SERVICE VISIT WAS PERFORMED. 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A PATIENT EXPERIENCED CORNEAL BURN DURING THE PHACOEMULSIFICATION STEP OF THE SURGERY WHILE USING THE HANDPIECE. THE EVENT OCCURRED DURING THE GROOVE AND QUADRANTS REMOVAL. THERE WAS NO ANY OCCLUSION BELL DURING THE PROCEDURE. THE SURGERY COULD BE COMPLETED. THE AFFECTED EYE IS UNKNOWN. THE PATIENT ALSO HAD INTRAOPERATIVE HYPOTONY, IRIS DAMAGE, IRIS PROLAPSE, WOUND LEAKAGE, MANY CONJUNCTIVAL HYPEREMIAS NEAR INCISION, CORNEAL EDEMA, CORNEAL OPACIFICATION AND ASTIGMATISM. THE PATIENT INITIALLY NEEDED 9 SUTURES. THERAPEUTIC CONTACT LENSES WERE PRESCRIBED AND THE PATIENT WAS ALSO TREATED WITH DEXAMETHASONE. FOURTEEN HOURS AFTER THE EVENT, IN THE CHECKUP, SEYDEL WAS OBSERVED DUE TO A DEHISCENCE OF THE WOUND. DURING REVISION ON A FURTHER DATE, AN IMPROVEMENT OF EDEMA AND HYPEREMIA WAS OBSERVED BUT THE SEYDEL PERSISTED. THREE MORE SUTURES WERE APPLIED ACHIEVING SEYDEL CESSATION. THE POSTOPERATIVE ASTIGMATISM WAS OF -3.75 X10º WHILE THE BASAL ONE WAS OF -0.5 X 80º. CONCOMITANT MEDICAL PRODUCT, ADMINISTERED PRE-SURGERY: NEPAFENAC, MOXIFLOXACIN AND TOBRAMYCIN. THE COMPANY REPRESENTATIVE INFORMED THAT IN THE SAME DAY OF THE EVENT ANOTHER PHYSICIAN OPERATED WITHOUT ANY PROBLEM. IN COMPANY REPRESENTATIVE´S OPINION THE EVENT COULD HAVE BEEN RELATED WITH THE INCISION BEING SMALLER THAN USUAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE. THERE IS A VIDEO OF THE SURGERY THAT CAN BE REQUESTED TO THE DOCTOR.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED BY THE OPHTHALMOLOGIST, WHO CONFIRMED THE EYE INVOLVED WAS THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513383 INFINITI VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other| R OZIL TORSIONAL PHACO HANDPIECE (SN, UNK)| TOBRAMYCIN| MOXIFLOXACIN