BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATINUM 1 SERIES

    MDR report key: 7021631 · Received November 10, 2017

    Report

    Report Number
    9614546-2017-01087
    Event Type
    Malfunction
    Date Received
    November 10, 2017
    Date of Event
    August 17, 2017
    Report Date
    January 29, 2018
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    KYB
    UDI-DI
    05050474552203
    PMA / PMN Number
    K081545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: IN REVIEWING THE INITIAL MDR, IT WAS DISCOVERED THAT THE INTRAOCULAR LENS ZCT150 +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 THE FOLLOWING FIELDS WERE UPDATED: 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. (B)(4). CONCOMITANT MEDICAL PRODUCTS: LENS ZCT150, SERIAL NUMBER (B)(4). (B)(4). PMA/510(K): K081545. AS A RESULT OF THE CHANGE TO THE REPORTED MANUFACTURER IN THE MANUFACTURER REPORT NUMBER IS UPDATED TO BEGIN WITH (B)(4). DEVICE MANUFACTURE DATE: UNKNOWN, AS THE LOT NUMBER WAS NOT PROVIDED. ADDITIONAL INFO: ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THERE WAS NO PATIENT INJURY AND NO COMPLICATIONS POST SURGERY WITH THE REPLACEMENT LENS. (B)(4). DEVICE EVALUATION: THE CARTRIDGE WAS NOT RETURNED AT THE MANUFACTURING SITE FOR EVALUATION. THEREFORE PRODUCT TESTING COULD NOT BE PERFORMED AND THE CUSTOMER'S REPORTED COMPLAINT COULD NOT BE VERIFIED. 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 COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH: UNKNOWN, INFORMATION NOT PROVIDED. GENDER/SEX: UNKNOWN, INFORMATION NOT PROVIDED. THE LENS WAS INSERTED AND REMOVED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HAPTIC OF A ZCT150 23.0 DIOPTER INTRAOCULAR LENS (IOL) (HAPTIC) TORE WHILE INSERTING INTO THE PATIENT'S OPERATIVE EYE BECAUSE IT GOT STUCK TO THE PLUNGER. PART OF THE LEADING HAPTIC TOUCHED THE EYE, BUT THE LENS WAS NOT FULLY INSERTED. THE DOCTOR REMOVED THE DAMAGED LENS AND REPLACED IT WITH A BACK UP LENS, WHICH WAS THE SAME MODEL AND DIOPTER DURING THE SAME PROCEDURE. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES USED. REPORTEDLY, THE PATIENT IS FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798825 PLATINUM 1 SERIES SURGICAL ADJUNCTS KYB ABBOTT MEDICAL OPTICS 1MTEC30 UNKNOWN 05050474552203

    Patients

    Seq Age Sex Outcome Treatment
    1 1MTEC30, LOT NUMBER UNKNOWN| LENS ZC150, SERIAL NUMBER (B)(4)