BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 11141149 · Received January 8, 2021

    Report

    Report Number
    2648035-2021-07049
    Event Type
    Malfunction
    Date Received
    January 8, 2021
    Report Date
    March 10, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474558328
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9. DEVICE AVAILABLE FOR EVALUATION? YES . RETURNED TO MANUFACTURER ON: 2/8/2021 . SECTION H3. DEVICE RETURNED TO MANUFACTURER? YES. DEVICE EVALUATION: VISUAL INSPECTION USING MAGNIFICATION WAS PERFORMED TO THE RETURNED SAMPLE. THE PLUNGER AND PUSHROD WAS OBSERVED IN ADVANCED POSITION. RESIDUES OF LUBRICANT MATERIAL WAS OBSERVED ON CARTRIDGE. THE CARTRIDGE TIP WAS OBSERVED DAMAGED AND DEFORMED. THE LENS WAS ALSO OBSERVED EXPOSED AND STUCK AT THE CARTRIDGE TIP SECTION. ONE PART OF THE LENS WAS OBSERVED BROKEN AND WITH ONE HAPTIC DETACHED. 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 AS LENS DAMAGED WAS VERIFIED. 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

    INFORMATION UNKNOWN, NOT PROVIDED. THERE WAS NO PATIENT CONTACT REPORTED. 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. PHONE: (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE LENS WAS DEFECTIVE. THE ISSUE WAS FIRST IDENTIFIED UPON OPENING OF THE PACKAGING, NO CONTACT WITH PATIENT'S EYE. NO PATIENT INVOLVEMENT/INJURY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34363 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. PCB00 05050474558328

    Patients

    Seq Age Sex Outcome Treatment
    1