BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1-PIECE

    MDR report key: 8388239 · Received March 4, 2019

    Report

    Report Number
    9614546-2019-00184
    Event Type
    Injury
    Date Received
    March 4, 2019
    Report Date
    November 9, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474531819
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION DEVICE AVAILABLE FOR EVALUATION: YES. RETURNED TO MANUFACTURER ON: 02/21/2019. DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE RETURNED TO MANUFACTURER: YES. DEVICE EVALUATION: THE PRODUCT WAS RECEIVED INSIDE ITS ORIGINAL BOX AND DAISY WHEEL. THE LENS WAS CUT IN HALF, MOST PROBABLY TO AID IN EXPLANT. DUE TO THE CONDITION OF THE LENS, FURTHER ANALYSIS IS NOT POSSIBLE. THE REPORTED ISSUE WAS NOT VERIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED, THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. HISTORICAL DATA ANALYSIS: A SEARCH REVEALED THAT NO ADDITIONAL/SIMILAR (AS APPLICABLE) COMPLAINTS FOR THIS ORDER NUMBER HAVE BEEN RECEIVED. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WERE REVIEWED, THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS ALONG WITH WARNINGS FOR THE PROPER USE AND HANDLING OF THE DEVICE. CONCLUSION: AS A RESULT, OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT MALFUNCTION OR PRODUCT QUALITY DEFICIENCY. THE REPORTED ISSUE WAS NOT VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS CORRECTION MDR IS BEING SUBMITTED TO ADDRESS INACCURATE INFORMATION IN SECTION F ON THE XML VERSION OF THE PREVIOUS SUBMISSION CAUSED BY A SOFTWARE GLITCH IN THE TRANSMISSION PROCESS. THE INTERNAL NON-CONFORMANCE NUMBERS FOR THIS SOFTWARE ISSUE ARE NR-0148919 AND CAPA-010215.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: IF IMPLANTED; GIVE DATE: IN THE INITIAL MDR THIS FIELD WAS INADVERTENTLY LEFT BLANK. THE DATE OF IMPLANT IS (B)(6) 2019. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    GENDER/SEX: UNKNOWN, INFORMATION NOT PROVIDED. DATE OF EVENT: UNKNOWN, NOT PROVIDED. IF IMPLANTED; GIVE DATE: UNKNOWN, NOT PROVIDED, AS IOL IMPLANT DATE WAS NOT PROVIDED. IF EXPLANTED; GIVE DATE: UNKNOWN, NOT PROVIDED, AS IOL EXPLANT DATE WAS NOT PROVIDED. (B)(4). ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER ACCOUNT REQUESTING ADDITIONAL INFORMATION HOWEVER, TO DATE NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED A ZCB00 25.0 DIOPTER INTRAOCULAR LENSES (IOL) WAS EXPLANTED FROM THE PATIENT¿S OCULAR SINISTER (LEFT EYE) DUE TO THE PATIENT¿S EYE ANATOMY BEING UNABLE TO SUPPORT THE ZCB00 LENS. IT WAS REPORTED A VITRECTOMY WAS PERFORMED AND THE PATIENT WAS LEFT APHAKIC FOR TWO (02) WEEKS TO HEAL. PATIENT RETURNED ON A LATER SURGERY DATE AND AN ANTERIOR CHAMBER (AC) IOL WAS INSERTED USING THE APPROPRIATE CARTRIDGE AND INJECTOR. THIS REPORT CAPTURES THE NONFOCAL EXPLANT EVENT. THE REPORTED MULTIFOCAL EXPLANT WILL BE CAPTURED IN A SEPARATE REPORT. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180542 TECNIS 1-PIECE MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. ZCB00 05050474531819

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention