BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATINUM 1 SERIES

    MDR report key: 7629396 · Received June 22, 2018

    Report

    Report Number
    3011852734-2018-00106
    Event Type
    Malfunction
    Date Received
    June 22, 2018
    Date of Event
    May 23, 2018
    Report Date
    July 30, 2018
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    KYB
    UDI-DI
    05050474540323
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE AVAILABLE FOR EVALUATION: YES. RETURNED TO MANUFACTURER ON: 06/25/2018. DEVICE RETURNED TO MANUFACTURER: YES. DEVICE EVALUATION: THE PRODUCT WAS RETURNED TO THE MANUFACTURING SITE FOR EVALUATION. VISUAL INSPECTION UNDER 12X MICROSCOPE MAGNIFICATION SHOWED THERE WAS A DEEP SCRATCH OBSERVED AT THE OPTIC ON THE ANTERIOR SIDE OF THE LENS. THIS TYPE OF DEFECT WILL BE REJECTED ACCORDING TO HB0017 ¿COSMETIC SPECIFICATION OF ACRYLIC ONE-PIECE LENSES¿. BOTH LENS HAPTIC WERE OBSERVED IN GOOD CONDITION AND NO ABNORMALITIES. LENS WAS FURTHER MEASURED AND WERE WITHIN SPECIFICATION. COMPLAINT EVENT ON CARTRIDGE CRACK IS NOT CONFIRMED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS ALONG WITH WARNINGS FOR THE PROPER USE AND HANDLING OF THE DEVICE. AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTION: IN REVIEW, THE CONCOMITANT MEDICAL PRODUCT IN SECTION D11 OF THE INITIAL EMDR WAS INCORRECTLY REPORTED AS ZCB00 23.5 DIOPTER LENS SERIAL (B)(6). THE CORRECT CONCOMITANT MEDICAL PRODUCT IS ZCB00 20.0 DIOPTER LENS SERIAL (B)(6). THIS SECTION HAS BEEN UPDATED TO REFLECT THE CORRECT INFORMATION. SECTION D11: CONCOMITANT MEDICAL PRODUCTS - ZCB00 20.0 DIOPTER LENS SERIAL (B)(4) ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT IMPLANTABLE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 1MTEC30 CARTRIDGE, IN USE WITH A ZCB00 23.5 DIOPTER LENS, SPLIT DURING INSERTION ON THE BODY AND THE TIP OF THE CARTRIDGE. REPORTEDLY, THERE WAS PATIENT CONTACT, NO PATIENT INJURY, AND THE PATIENT IS DOING FINE POST-OPERATIVELY. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473847 PLATINUM 1 SERIES UNFOLDER CARTRIDGE KYB JOHNSON & JOHNSON SURGICAL VISION, INC. 1MTEC30 05050474540323

    Patients

    Seq Age Sex Outcome Treatment
    1 ZCB00 20.0 DIOPTER LENS SERIAL (B)(6)| ZCB00 23.5 DIOPTER LENS SERIAL (B)(6)