BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY PRELOADED 1-PIECE IOL

    MDR report key: 11061277 · Received December 22, 2020

    Report

    Report Number
    2648035-2020-00956
    Event Type
    Malfunction
    Date Received
    December 22, 2020
    Date of Event
    November 25, 2020
    Report Date
    February 19, 2021
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474636002
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D10: DEVICE AVAILABLE FOR EVALUATION: YES SECTION D10: RETURNED TO MANUFACTURER ON: 1/25/2021 SECTION H3: DEVICE RETURNED TO MANUFACTURER: YES. DEVICE EVALUATION: THE PRODUCT WAS RETURNED IN ITS ORIGINAL PACKAGING. UPON EVALUATION THE PLUNGER WAS IN A FULLY ADVANCED POSITION. ALL THE COMPONENTS WERE CORRECTLY ENGAGED, AND THE PLUNGER WAS CENTERED. NO ASSEMBLY ERROR AND/OR DEFECT RELATED TO MANUFACTURING PROCESS WERE OBSERVED. TRACES OF LUBRICANT MATERIAL RESIDUES WERE OBSERVED IN THE DEVICE. THE LENS WAS RECEIVED OUTSIDE THE DEVICE ATTACHED TO ADHESIVE TAPE AND THE HAPTICS LOOK SLIGHTLY DISTORTED. ALSO, THE TIP OF CARTRIDGE WAS DAMAGED/DEFORMED. THE CONDITIONS OBSERVED ARE ASSOCIATED TO HANDLING. DUE TO THE CONDITION OF THE SAMPLE RETURNED THE REPORTED ISSUE WAS NOT VERIFIED, AND PRODUCT QUALITY DEFICIENCY COULD NOT BE DETERMINED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. THERE ARE NO DISCREPANCIES FOUND DURING THE MRR (MANUFACTURING RECORD REVIEW). A SEARCH REVEALED THAT NO ADDITIONAL COMPLAINT WAS RECEIVED FROM THIS PRODUCTION ORDER. 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

    IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS NOT IMPLANTED. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS NOT IMPLANTED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DCB00 MODEL INTRAOCULAR LENS COULD NOT BE ADVANCE THE AT FIRST AND FINALLY WHEN LENS WAS ADVANCED THE SURGEON DID NOT LIKE THE WAY THE LENS LOOKED. THERE WAS NO PATIENT CONTACT, PATIENT INJURY OR MEDICAL INTERVENTIONS WERE REQUIRED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1523149 TECNIS SIMPLICITY PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. DCB00 05050474636002

    Patients

    Seq Age Sex Outcome Treatment
    1