BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS 1-PIECE IOL WITH THE TECNIS ITEC PRELOADED DELIVERY SYSTEM

    MDR report key: 11742473 · Received April 28, 2021

    Report

    Report Number
    2648035-2021-07704
    Event Type
    Malfunction
    Date Received
    April 28, 2021
    Date of Event
    March 29, 2021
    Report Date
    June 16, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474558144
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D9 - DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D9 - RETURNED TO MANUFACTURER ON: 4/30/2021. SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: VISUAL INSPECTION WAS PERFORMED ON THE INTRAOCULAR LENS (IOL) RETURNED. THE PLUNGER AND PUSHROD WAS OBSERVED IN ADVANCED POSITION. THE PUSHROD WAS OBSERVED THAT OVERRIDES THE LENS IN THE CARTRIDGE. THIS PROBABLY COULD HAVE CAUSED THE LENS TO GET DAMAGED DURING THIS PROCESS. RESIDUES OF VISCOELASTIC MATERIAL WAS OBSERVED ON CARTRIDGE. THE CARTRIDGE TIP WAS OBSERVED DEFORMED. THE LENS WAS ALSO OBSERVED STUCK IN CARTRIDGE. 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 PREPARE FOR SURGICAL PROCESS. THE COMPLAINT ISSUE REPORTED COULD NOT BE VERIFIED. MANUFACTURING RECORD EVALUATION: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH REVEALED THAT NO ADDITIONAL COMPLAINTS FOR THIS ORDER NUMBER HAVE BEEN RECEIVED. 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

    IF IMPLANTED; GIVE DATE: NOT APPLICABLE, THE LENS WAS NOT IMPLANTED. IF EXPLANTED; GIVE DATE: NOT APPLICABLE, THE LENS WAS NOT IMPLANTED. PHONE: (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED ISSUES WITH A MODEL PCB00 INTRAOCULAR LENS (IOL). THE LENS GOT DAMAGED DURING HANDLING BUT PRIOR INSERTION INTO THE PATIENT'S EYE. NO CONTACT WITH PATIENT'S EYE, THE LENS IS NOT BIOLOGICALLY CONTAMINATED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632595 TECNIS 1-PIECE IOL WITH THE TECNIS ITEC PRELOADED DELIVERY SYSTEM POSTERIOR-CHAMBER INTRAOCULAR LENS, PSEUDOPHAKIC HQL AMO PUERTO RICO MFG. INC. PCB00 05050474558144

    Patients

    Seq Age Sex Outcome Treatment
    1