BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE IRRIGATION AND ASPIRATION TIPS

    MDR report key: 5001075 · Received August 13, 2015

    Report

    Report Number
    2523835-2015-00799
    Event Type
    Injury
    Date Received
    August 13, 2015
    Date of Event
    July 17, 2015
    Report Date
    November 20, 2015
    Manufacturer
    ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE
    Product Code
    KYG
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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 ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Additional Manufacturer Narrative · 1

    NO SAMPLE HAS BEEN RETURNED FOR EVALUATION; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. THE FINAL CUSTOMER LOT WAS IDENTIFIED AS STERILE LOT 112062M. A DEVICE HISTORY RECORD REVIEW FOR THE LOT WAS CONDUCTED. NO ANOMALY WAS FOUND DURING THE DEVICE HISTORY RECORD REVIEW. THE PRODUCT WAS RELEASED BASED ON ALCON¿S ACCEPTANCE CRITERIA. NO ADDITIONAL INVESTIGATION IS REQUIRED BASED ON DEVICE HISTORY REVIEW. A COMPLAINT HISTORY REVIEW INDICATES THIS IS THE SECOND COMPLAINT ASSOCIATED WITH THE REPORTED LOT. BECAUSE NO SAMPLE WAS RETURNED AND THE DEVICE HISTORY REVIEW (DHR) OF THE LOT NUMBER PROVIDED INDICATED PRODUCT WAS RELEASED ACCORDING TO ALCON¿S ACCEPTANCE CRITERIA, THE ROOT CAUSE FOR THE DEFECT EXPERIENCED BY THE CUSTOMER CANNOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS IMPLANT PROCEDURE THERE WERE FOUR PATIENTS THAT EXPERIENCED POSTERIOR CAPSULE TEARS (PC TEAR). THE SURGEON SUSPECTS THE IRRIGATION/ASPIRATION TIP TO HAVE CAUSED THE PC TEARS. THIS REPORT IS FOR THE FOURTH OF THE FOUR PATIENT FOR THIS REPORTED EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NONE HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533628 SILICONE IRRIGATION AND ASPIRATION TIPS DEVICE, IRRIGATION, OCULAR SURGERY KYG ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE NA 112062M

    Patients

    Seq Age Sex Outcome Treatment
    1 Other AMO SOVEREIGN SYSTEM