BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATINUM 1 SERIES

    MDR report key: 11151922 · Received January 11, 2021

    Report

    Report Number
    2648035-2021-07034
    Event Type
    Malfunction
    Date Received
    January 11, 2021
    Date of Event
    December 14, 2020
    Report Date
    March 12, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    KYB
    PMA / PMN Number
    K081545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: IN REVIEW OF SECTION E IN FOLLOW-UP 1, THE COUNTRY WAS INADVERTENTLY SELECTED AS UNITED STATES, HOWEVER, THE COUNTRY SHOULD HAVE BEEN NETHERLANDS. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION B5 - DESCRIBE EVENT OR PROBLEM: THE CARTRIDGE WAS DISCARDED WHILE THE PARTICLE REMAINS IN THE YE PENDING FURTHER POST-OPERATIVE CHECKS. THE CARTRIDGE MODEL WAS IDENTIFIED AS A 1MTEC30. NO ADDITIONAL INFORMATION WAS PROVIDED. SECTION D1 - BRAND NAME: PLATINUM 1 SERIES. SECTION D4 - MODEL #: 1MTEC30. SECTION D4 - CATALOGUE#:1MTEC30. SECTION G4 - PMA/510(K) #: K081545. DEVICE EVALUATION: NO MATERIAL WAS RETURNED FOR EVALUATION AS IT WAS EITHER DISCARDED OR REMAINS IMPLANTED IN THE PATIENTS EYE. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED. MANUFACTURING RECORD EVALUATION: THE MANUFACTURING RECORDS FOR THE CARTRIDGE COULD NOT BE REVIEWED AS THE LOT NUMBER COULD NOT BE PROVIDED. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    IF IMPLANTED; GIVE DATE: N/A. THE CARTRIDGE IS NOT AN IMPLANTABLE DEVICE. IF EXPLANTED; GIVE DATE: N/A. THE CARTRIDGE IS NOT AN IMPLANTABLE DEVICE; THEREFORE, NOT EXPLANTED. PHONE: (B)(6). PMA/510(K) NUMBER: UNKNOWN AS PRODUCT LOT NUMBER WAS NOT PROVIDED. DEVICE MANUFACTURE DATE: UNKNOWN AS PRODUCT LOT NUMBER WAS NOT PROVIDED. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION. HOWEVER, TO DATE, NO FURTHER DETAILS COULD BE PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PIECE OF THE INTRAOCULAR LENS (IOL) CARTRIDGE HAS TORN OFF AND NOW IS LOCATED IN THE SULCUS. THE SURGEON TRIED TO REMOVE THE PIECE BUT UNFORTUNATELY FAILED. THE DOCTOR WAS PUT IN TOUCH WITH OUR MEDICAL ADVISOR AND WAS ADVISED TO REMOVE THE PIECE. DOCTOR HAS TOLD US THAT HE IS GOING TO FOLLOW UP WITH THE PATIENT AND TRY TO REMOVE THE PIECE LATER. MATERIAL IS NOT AVAILABLE (DISCARDED) AND SO FAR NO ADVERSE EFFECTS ON THE PATIENT HAVE BEEN REPORTED. THROUGH FOLLOW-UP WE LEARNED THAT THE PIECE REMAINS IN THE EYE AND THAT THE ISSUE OCCURRED ON THE (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47818 PLATINUM 1 SERIES CARTRIDGE KYB AMO PUERTO RICO MFG. INC. 1MTEC30

    Patients

    Seq Age Sex Outcome Treatment
    1