BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 12558607 · Received September 30, 2021

    Report

    Report Number
    2020664-2021-07419
    Event Type
    Injury
    Date Received
    September 30, 2021
    Date of Event
    May 6, 2015
    Report Date
    January 26, 2022
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474560642
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: THE CUSTOMER PROVIDED FOLLOW-UP INFORMATION EXPLAINING THAT THE INITIAL EXPLANT DATE THEY PROVIDED OF (B)(6). 2021 WAS INCORRECT. REPORTED IN MEDWATCH MD-0005283. THE CORRECT EXPLANT DATE IS (B)(6). 2021. THEREFORE, THIS SUPPLEMENTAL FILING IS TO CORRECT SECTION D6B. SECTION D6B IF EXPLANTED; GIVE DATE: (B)(6). 2021. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC., HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9: DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D9: DATE RETURNED TO MANUFACTURER: NOV 11, 2021. ADDITIONAL INFORMATION: DEVICE EVALUATION: THE COMPLAINT LENS WAS RECEIVED IN A SPECIMEN CUP. NO ADDITIONAL PRODUCT WAS RECEIVED AS PART OF THIS RETURN. A CUP CONTAINING THE LENS WAS RECEIVED WITH WRITING ON IT. IT STATES OD ON (B)(6) 2021. VISUAL INSPECTION UNDER MAGNIFICATION REVEALED VISCOELASTIC RESIDUE ON THE OPTIC BODY AND HAPTICS AND THAT THE LENS WAS RECEIVED CUT IN HALF, WHICH IS CONSISTENT WITH A LENS THAT WAS HANDLED DURING EXPLANT. BASED ON THE RETURN CONDITION OF THE LENS, NO FURTHER PRODUCT EVALUATION COULD BE PERFORMED. A PRODUCT QUALITY DEFICIENCY COULD NOT BE DETERMINED. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. REGARDING THE ADDITIONAL INFORMATION ON THE SPECIMEN CUP THAT STATES OD (RIGHT EYE) ON (B)(6) 2021. THE INFORMATION IMPLIES THE EXPLANT DATE IS ON (B)(6) 2021 WHICH DIFFERS FROM THE EXPLANT DATE INITIALLY PROVIDED BY THE CUSTOMER ON (B)(6) 2021. FOLLOW-UP WAS DONE TO GET CLARIFICATION. HOWEVER NO RESPONSE HAS BEEN RECEIVED. IF A RESPONSE IS RECEIVED CLARIFYING THE CORRECT DATE IS ON (B)(6) 2021 THEN A FOLLOW-UP REPORT WILL BE SUBMITTED TO THE FDA. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: DEVICE EVALUATION: PRODUCT TESTING COULD NOT BE PERFORMED AS THE PRODUCT WAS NOT RETURNED. THE REPORTED EVENT COULD NOT BE VERIFIED, AND NO PRODUCT DEFICIENCY COULD BE IDENTIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH REVEALED ANOTHER COMPLAINT WAS FOR THIS PRODUCTION ORDER BUT UNRELATED TO THIS INVESTIGATION. CONCLUSION: BASED ON THE INVESTIGATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: PATIENT WEIGHT: UNKNOWN/NO INFORMATION. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC., HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    RECEIVED REPORT INDICATING THAT THE INTRAOCULAR LENS (IOL), MODEL ZLB00, WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE DUE TO EXPERIENCING HALOS, STARBURST AND POOR VISION. THE DOCTOR CLARIFIED THAT THE PATIENT HAD FRONTAL ARCUATE INCISIONS OVERCORRECTING HIS ASTIGMATISM. THE REPLACEMENT LENS WAS ANOTHER JOHNSON AND JOHNSON LENS OF DIFFERENT MODEL AND DIOPTER. THERE WAS NO PATIENT INJURY REPORTED AND NO FURTHER INTERVENTION WAS REQUIRED. REPORTEDLY THE PATIENT OUTCOME IS EXCELLENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1455816 TECNIS IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS ZLB00 05050474560642

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention