BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 11125450 · Received January 6, 2021

    Report

    Report Number
    2648035-2020-05014
    Event Type
    Malfunction
    Date Received
    January 6, 2021
    Date of Event
    December 8, 2020
    Report Date
    April 12, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474558281
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: SECTION H6: CORRECTION: HEALTH EFFECT - CLINICAL CODE: IN INITIAL REPORT, THE HEALTH EFFECT - CLINICAL CODE SHOULD HAVE INDICATED: 4582 - NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS DEVICE EVALUATION: VISUAL INSPECTION USING MAGNIFICATION WAS PERFORMED TO THE RETURNED SAMPLE. THE PLUNGER AND PUSHROD WAS OBSERVED IN ADVANCED POSITION THE PUSHROD WAS OBSERVED THAT OVERRIDES THE LENS IN THE CARTRIDGE. RESIDUES OF LUBRICATING MATERIAL WERE OBSERVED ON CARTRIDGE. NO DAMAGED WAS OBSERVED TO THE CARTRIDGE. THE LENS WAS ALSO OBSERVED STUCK IN CARTRIDGE. IT WAS TOO HARD TO REMOVE THE LENS FROM THE CARTRIDGE TO ADDRESS THE LENS DAMAGE CONDITION REPORTED. BASED ON THE SAMPLE EVALUATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE COMPLAINT UNIT HAS BEEN AFFECTED BY THE MANUFACTURING PROCESS. THE CONDITION IN WHICH THE SAMPLE RETURNED IS CONSISTENT WITH A PRODUCT THAT WAS HANDLED AND PREPARED FOR A SURGICAL PROCESS. THE COMPLAINT ISSUE REPORTED COULD NOT BE VERIFIED. MANUFACTURING RECORD EVALUATION: THE MANUFACTURING RECORDS FOR THE DEVICE WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH OF COMPLAINTS RELATED THIS PRODUCTION ORDER WAS PERFORMED. THE SEARCH REVEALED THREE ADDITIONAL INVESTIGATION REQUESTS FOR THIS PRODUCTION ORDER NUMBER. PRODUCT DEFICIENCY NOT IDENTIFIED 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

    NOT APPLICABLE AS THERE WAS NO PATIENT CONTACT. IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS NOT IMPLANTED. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS NOT IMPLANTED THEREFORE NOT REMOVED. 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 BY THE CUSTOMER THAT AN INTRAOCULAR LENS (IOL) WAS DEFECTIVE. THERE WAS NO PATIENT CONTACT WITH THE PRODUCT. THERE WAS NO OTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18233 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. PCB00 05050474558281

    Patients

    Seq Age Sex Outcome Treatment
    1