BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 12454264 · Received September 10, 2021

    Report

    Report Number
    2020664-2021-07323
    Event Type
    Injury
    Date Received
    September 10, 2021
    Date of Event
    December 1, 2020
    Report Date
    November 19, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474531598
    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

    ADDITIONAL INFORMATION: SECTION D9: DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D9: RETURNED TO MANUFACTURER ON: SEP 28, 2021. SECTION H3: DEVICE EVALUATED BY MANUFACTURER¿ YES. DEVICE EVALUATION: 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. THE COMPLAINT ISSUE COULD NOT BE CONFIRMED, AND NO PRODUCT DEFICIENCY COULD BE IDENTIFIED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. THE SEARCH REVEALED THAT NO SIMILAR COMPLAINT FOR THIS PRODUCTION ORDER NUMBER HAS BEEN RECEIVED. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE CONFIRMED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT: UNKNOWN/ASKED BUT UNAVAILABLE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO A DISLOCATED IOL BAG COMPLEX. A PARS PLANA VITRECTOMY (PPV) WAS REQUIRED, HOWEVER, AN INCISION ENLARGEMENT WAS NOT REQUIRED. ALSO NOTED GONIOTOMY, YAMANE INTRASCLERAL HAPTIC FIXATION. THE PROCEDURE WAS COMPLETED WITH AN NON-JOHNSON & JOHNSON REPLACEMENT LENS. THERE WAS NO PATIENT INJURY. THE PATIENT OUTCOME WAS EXCELLENT POST-OPERATIVE (OP). NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1352687 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. ZCB00 05050474531598

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention