BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNFOLDER PLATINUM 1 SERIES

    MDR report key: 11593935 · Received March 31, 2021

    Report

    Report Number
    2648035-2021-07480
    Event Type
    Malfunction
    Date Received
    March 31, 2021
    Date of Event
    March 2, 2021
    Report Date
    April 16, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    KYB
    UDI-DI
    05050474540323
    PMA / PMN Number
    K081545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H6: HEALTH EFFECT - IMPACT CODE: 3191 DEVICE EVALUATION: PRODUCT TESTING COULD NOT BE PERFORMED SINCE THE PRODUCT WAS NOT RETURNED FOR EVALUATION. THEREFORE, THE REPORTED ISSUE COULD NOT BE VERIFIED, AND PRODUCT QUALITY DEFICIENCY COULD NOT BE DETERMINED. MANUFACTURING RECORD EVALUATION: THE MANUFACTURING RECORDS FOR THE DEVICE WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH REVEALED THAT NO ADDITIONAL COMPLAINTS FOR THIS ORDER NUMBER HAVE BEEN RECEIVED. 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: NOT APPLICABLE, THE CARTRIDGE IS NOT AN IMPLANTABLE DEVICE. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, THE CARTRIDGE IS NOT AN IMPLANTABLE DEVICE. TELEPHONE NUMBER: (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN ONE OF THE PROCEDURES IT WAS NECESSARY TO INCREASE THE INCISION OF 2.2 MM BECAUSE SURGEON ALLEGED THE CARTRIDGE GAUGE IS NOT COMPATIBLE TO THE INCISION SIZE. IN THIS CASE THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENTS ENDOTHELIUM WITH MANIPULATIONS TO INSERT THE LENS INTO THE BAG. IT WAS THE SIZE OF THE INCISION TO ACCOMMODATE THE CARTRIDGE THAT CAUSED DISCOMFORT DURING THE IMPLANT. LENS WAS FULLY INSERTED INTO THE EYE. ADDITIONAL INFORMATION STATES THAT TIP OF THE CARTRIDGE IS NOT CORRESPONDENT TO THE INCISION OF 2.2 MM, CAUSING THE DIFFICULTY DURING THE INSERTION OF THE IOL. THERE WAS ALSO CORNEAL EDEMA NEAR TO THE INCISION. NO OTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497079 UNFOLDER PLATINUM 1 SERIES LENS, GUIDE, INTRAOCULAR KYB AMO PUERTO RICO MFG. INC. 1MTEC30 CH11853 05050474540323

    Patients

    Seq Age Sex Outcome Treatment
    1 ZCT150 LENS SN: (B)(6)