BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 7512865 · Received May 14, 2018

    Report

    Report Number
    9614546-2018-00465
    Event Type
    Injury
    Date Received
    May 14, 2018
    Report Date
    October 20, 2018
    Manufacturer
    JOHNSON AND JOHNSON SURGICAL VISION, INC.
    Product Code
    MFK
    UDI-DI
    05050474560598
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE PRODUCT TESTING COULD NOT BE PERFORMED AS THE PRODUCT WAS NOT RETURNED. THE REPORTED COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING PROCESS RECORD WAS EVALUATED AND NO DEVIATION WAS FOUND DURING PROCESS RELATED TO THE COMPLAINT ISSUE REPORTED. THERE WAS NO DISCREPANCY FOUND DURING THE MRR (MANUFACTURING RECORD REVIEW). THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH REVEALED THAT NO SIMILAR COMPLAINTS WERE RECEIVED FOR THIS PRODUCTION ORDER. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS FOR THE PROPER USE AND HANDLING OF THE PRODUCT. CONCLUSION: BASED ON THE INVESTIGATION RESULTS 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 · 0

    PER RECENT FOLLOW-UP INFORMATION, THE PHYSICIAN HAS SCHEDULED AN EXPLANT ON (B)(6) 2018 AND WAS REQUESTING FOR ZXR00 INTRAOCULAR LENS (IOL) WITH 16.0 AND 15.5 DIOPTER. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: IF EXPLANTED; GIVE DATE: (B)(6) 2018. ADDITIONAL INFORMATION WAS RECEIVED AS FOLLOWS: THE INTRAOCULAR LENS WAS RECEIVED AT THE JOHNSON AND JOHNSON LAB; CONFIRMING LENS WAS EXPLANTED AS PLANNED ON (B)(6) 2018. THERE WAS NO PATIENT INJURY OR SURGICAL INTERVENTION REQUIRED AT EXPLANT. PATIENT WAS DOING OKAY POST-SURGERY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    DEVICE AVAILABLE FOR EVALUATION? YES. RETURNED TO MANUFACTURER ON: 8/24/2018. DEVICE RETURNED TO MANUFACTURER? YES. DEVICE EVALUATION: THE PRODUCT WAS RECEIVED IN A LENS CASE. VISUAL INSPECTION WITH THE UNAIDED EYE SHOWS THAT THE PRODUCT IS CUT IN PIECES, MOST PROBABLY TO MAKE EXPLANT POSSIBLE. CONSIDERING THE CONDITION OF THE LENS, ADDITIONAL ANALYSIS IS NOT POSSIBLE. THE COMPLAINT CANNOT BE CONFIRMED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    HOWEVER, AN EXPLANT IS PLANNED FOR (B)(6) 2018. (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 THAT THE PATIENT WAS UNHAPPY WITH HIS/HER VISION AND HAS REQUESTED AN INTRAOCULAR LENS (IOL) EXCHANGE. THE PATIENT HAD COMPLETELY UNEVENTFUL SURGERY AND IS EXPERIENCING MONOCULAR DIPLOPIA. THE LENS EXCHANGE IS EXPECTED TO BE IN (B)(6). THERE WAS NO INJURY OR PRIOR SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON AND JOHNSON SURGICAL VISION, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355354 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK JOHNSON AND JOHNSON SURGICAL VISION, INC. ZLB00 05050474560598

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention