BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATINUM 1 SERIES

    MDR report key: 7046397 · Received November 20, 2017

    Report

    Report Number
    9614546-2017-01129
    Event Type
    Malfunction
    Date Received
    November 20, 2017
    Date of Event
    October 20, 2017
    Report Date
    March 19, 2018
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    KYB
    UDI-DI
    05050474574168
    PMA / PMN Number
    K081545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: IN THE INITIAL MDR THE INTRAOCULAR LENS ZXT100 +23.0 (SERIAL NUMBER (B)(4)) WAS INCORRECTLY REPORTED AS SUSPECT MEDICAL DEVICE; INSTEAD THE CARTRIDGE 1MTEC30 SHOULD HAVE BEEN REPORTED AS SUSPECT MEDICAL DEVICE IN SECTION D. THEREFORE UPDATED THE FOLLOWING FIELDS: BRAND NAME: PLATINUM 1 SERIES. COMMON DEVICE NAME: SURGICAL ADJUNCTS. PRODUCT CODE: KYB/ MODEL #: 1MTEC30, CATALOG #: 1MTEC30, LOT NUMBER: UNKNOWN, NOT PROVIDED. EXPIRATION DATE: UNKNOWN, AS THE LOT NUMBER WAS NOT PROVIDED. UNIQUE IDENTIFIER (UDI#): (B)(4). CONCOMITANT MEDICAL PRODUCTS: LENS ZXT100, SERIAL NUMBER (B)(4). (B)(6). PMA/510(K): K081545. DEVICE MANUFACTURE DATE: UNKNOWN, AS THE LOT NUMBER WAS NOT PROVIDED. ADDITIONAL INFO: DEVICE AVAILABLE FOR EVALUATION? YES. RETURNED TO MANUFACTURER ON: 12/04/2017. DEVICE RETURNED TO MANUFACTURER? YES. DEVICE EVALUATION: THE CARTRIDGE WAS RETURNED AT THE MANUFACTURING SITE FOR EVALUATION. VISUAL INSPECTION AT 10X MICROSCOPE MAGNIFICATION SHOWED SCARCE AMOUNT OF VISCOELASTIC RESIDUE IN THE CARTRIDGE TUBE. AN INTRAOCULAR LENS (IOL) WAS OBSERVED STUCK IN THE CARTRIDGE TUBE WITH PART OF THE HAPTIC OUT OF THE CARTRIDGE TIP. THE CARTRIDGE WAS OBSERVED BROKEN BETWEEN THE TUBE AND THE TIP. THIS CONDITION APPEARS TO BE CAUSED BY THE PUSHROD HANDPIECE DUE TO THE SCARCE AMOUNT OF VISCOELASTIC USED WHICH COULD CAUSE RESISTANCE TO THE PUSHROD LEADING THE CARTRIDGE TO BREAK. THE CUSTOMER'S REPORTED COMPLAINT WAS VERIFIED; HOWEVER, IT COULD NOT BE RELATED TO THE MANUFACTURING PROCESS, BUT IT COULD BE RELATED TO THE HANDLING PROCESS. MANUFACTURING RECORDS REVIEW: THE LOT NUMBER IS UNKNOWN; THEREFORE THE MANUFACTURING RECORDS COULD NOT BE REVIEWED. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS ALONG WITH WARNINGS FOR THE PROPER USE AND HANDLING OF THE DEVICE. THE DFU STATES TO FILL THE ENTIRE INSIDE OF THE CARTRIDGE WITH VISCOELASTIC. AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE WAS VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: ADDITIONAL INFORMATION WAS RECEIVED AND THE LOT NUMBER OF THE CARTRIDGE WAS PROVIDED (CC05976). REPORTEDLY, THERE WAS A HOLE IN THE TIP OF THE CARTRIDGE. THE CARTRIDGE WAS INSIDE THE EYE AS THE SURGEON WAS TRYING TO INSERT THE INTRAOCULAR LENS WHEN THE PROBLEM OCCURRED. THERE WAS NO INJURY TO THE PATIENT. THE INJECTOR USED WAS THE PLATINUM SERIES DK7796 LOT 107. THE ACCOUNT COMMENTED THAT IT DID NOT APPEAR TO BE ANYTHING WRONG WITH THE INSERTER WHEN THEY LOOKED AT IT AFTER THE PROBLEM OCCURRED. UPDATED THE FOLLOWING FIELDS: LOT NUMBER: CC05976. EXPIRATION DATE: 5/19/2018. UNIQUE IDENTIFIER (UDI#): (B)(4). CONCOMITANT MEDICAL PRODUCTS: INJECTOR DK7796, LOT 107. DEVICE MANUFACTURE DATE: 5/19/2017. (B)(4). MANUFACTURING RECORDS REVIEW: AS THE LOT NUMBER WAS PROVIDED, THE MANUFACTURING RECORDS FOR THE CARTRIDGE WERE REVIEWED. DURING THE MANUFACTURING PROCESS THE OPERATORS CHECK THE NECK, TUBE AND TIP AREAS FOR CRACKS. NO CRACKING OR STRESS MARKS ARE ALLOWED. THE OPERATORS ALSO CHECK THE TIP FOR ANY MELTING, ROUGHNESS, DENT, BENT TIP OR SMASH CONDITION. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH REVEALED THAT NO ADDITIONAL COMPLAINTS FOR THIS ORDER NUMBER HAVE BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A ZXT100 23.0 DIOPTER INTRAOCULAR LENS (IOL) CAME OUT HALF WAY WHILE BEING INSERTED INTO THE EYE, AS IT SEEMED TO STICK TO THE BARREL. AS THE DOCTOR CONTINUED TO SCREW THE PLUNGER FORWARD, THE PLUNGER BROKE THROUGH THE SIDE OF THE CARTRIDGE AND FORCED THE LENS AND CARTRIDGE BACK OUT OF THE WOUND. REPORTEDLY, WHEN THE LENS WAS LOADED, THERE WAS NO RESISTANCE WHEN ENGAGING THE INJECTOR. THEREFORE, THE LENS WAS WITHDRAWN AND A BACK UP LENS WAS USED SUCCESSFULLY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824333 PLATINUM 1 SERIES SURGICAL ADJUNCTS KYB ABBOTT MEDICAL OPTICS 1MTEC30 CC05976 05050474574168

    Patients

    Seq Age Sex Outcome Treatment
    1 INJECTOR DK7796, LOT 107| LENS ZXT100, SERIAL NUMBER (B)(4) | UNKNOWN CARTRIDGE AND LOT NUMBER