BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 16633214 · Received March 28, 2023

    Report

    Report Number
    3012236936-2023-00749
    Event Type
    Malfunction
    Date Received
    March 28, 2023
    Date of Event
    March 3, 2023
    Report Date
    July 28, 2023
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    HQL
    UDI-DI
    05050474709683
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S EYE DUE TO SCRATCHES ON THE OPTIC OF THE IOL. THERE WAS NO REPORTED PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED. SECTION B1 REPORT TYPE: ADVERSE EVENT. SECTION B2 OUTCOMES ATTRIBUTED TO ADVERSE EVENT: REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE (DEVICES) SECTION B3 DATE OF EVENT: MARCH 3, 2023. SECTION D6A. IF IMPLANTED, GIVE DATE: (B)(6) 2023. SECTION D6B. IF EXPLANTED, GIVE DATE: (B)(6) 2023. SECTION H6 HEALTH EFFECT - IMPACT CODE: 4629 DEVICE REVISION OR REPLACEMENT ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9: DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D9: RETURNED TO MANUFACTURER ON: JUNE 9, 2023. SECTION H3: DEVICE EVALUATED BY MANUFACTURER¿ YES. DEVICE EVALUATION: THE COMPLAINT LENS WAS RECEIVED INSIDE OF A SPECIMEN CUP. VISUAL INSPECTION UNDER MAGNIFICATION REVEALED THAT THE COMPLAINT LENS WAS RECEIVED COATED IN VISCOELASTIC RESIDUE AND WITH THE LENS CUT NEAR THE HAPTIC OPTIC JUNCTION. THE LENS WAS CLEANED AND, TWO SCRATCHES COULD BE IDENTIFIED ON THE OPTIC OF THE LENS AS WELL AS TWO SCRATCHES ON THE SPARE TIRE. NO HANDPIECE WAS RECEIVED AS PART OF THIS RETURN. AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER NAME AND ADDRESS: TELEPHONE NUMBER: (B)(6). DEVICE EVALUATION: THE DEVICE WAS NOT RETURNED AT THE MANUFACTURING SITE AS IT REMAINS IMPLANTED; THEREFORE, PRODUCT TESTING COULD NOT BE PERFORMED AND THE CUSTOMER¿S REPORTED COMPLAINT COULD NOT BE VERIFIED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. A SEARCH OF COMPLAINTS RELATED TO THIS PRODUCTION ORDER (PO) WAS PERFORMED. THE SEARCH REVEALED THAT THERE WERE NO OTHER COMPLAINTS FOR THIS PO. NO ESCALATION WAS REQUIRED. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY, AND THE REPORTED ISSUE COULD NOT BE CONFIRMED. ATTEMPTS WERE MADE TO OBTAIN THE MISSING INFORMATION; HOWEVER, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A LINE-LIKE SCRATCH WAS FOUND ON THE LENS OF THE INTRAOCULAR LENS (IOL) AFTER IMPLANTATION. THE PATIENT'S VISUAL ACUITY WAS NOTED AS NOT IMPROVING. THERE WAS NO REPORTED PATIENT INJURY. THE IOL REMAINS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1713555 TECNIS IOL LENS, MULTIFOCAL INTRAOCULAR HQL AMO MANUFACTURING NETHERLANDS DFR00V 05050474709683

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention