BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 11175721 · Received January 14, 2021

    Report

    Report Number
    2648035-2021-07076
    Event Type
    Malfunction
    Date Received
    January 14, 2021
    Report Date
    March 10, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474558298
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D9 - DEVICE AVAILABILITY :YES. SECTION D9 - RETURNED TO MANUFACTURER TICKED. SECTION H3 - DEVICE EVALUATED BY MANUFACTURER YES. 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. THE CARTRIDGE TIP WAS OBSERVED DEFORMED. THE LENS WAS OBSERVED STUCK AT THE CARTRIDGE TIP SECTION. IT WAS TOO HARD TO REMOVE THE LENS FROM THE CARTRIDGE TO ADDRESS THE 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. BASED ON THE ANALYSIS OF THE RETURNED, THERE IS NO INDICATION OF PRODUCT QUALITY DEFICIENCY. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. THE SEARCH REVEALED THAT NO SIMILAR COMPLAINT FOR THIS PRODUCTION ORDER NUMBER HAS BEEN RECEIVED. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    NOT APPLICABLE. THERE WAS NO PATIENT CONTACT REPORTED. DATE OF EVENT: DATE UNKNOWN/ NOT PROVIDED. IF IMPLANTED; GIVE DATE: NOT APPLICABLE, THERE WAS NO PATIENT CONTACT, LENS WAS NOT IMPLANTED. IF EXPLANTED; GIVE DATE: NOT APPLICABLE, THERE WAS NO PATIENT CONTACT, LENS WAS NOT IMPLANTED, THEREFORE NOT EXPLANTED.(B)(6). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS AN ISSUE WITH PCB00 INTRAOCULAR LENS. CUSTOMER MENTIONED THAT THE LENS WAS DEFECTIVE, NO MORE INFORMATION IS AVAILABLE. NO CONTACT WITH THE PATIENTS EYE, NO PATIENT INVOLVEMENT. ISSUE FIRST IDENTIFIED UPON OPENING OF THE PACKAGING. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71222 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. PCB00 05050474558298

    Patients

    Seq Age Sex Outcome Treatment
    1