BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 16766196 · Received April 18, 2023

    Report

    Report Number
    3012236936-2023-00758
    Event Type
    Injury
    Date Received
    April 18, 2023
    Report Date
    August 29, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MFK
    UDI-DI
    05050474750678
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A4: PATIENT WEIGHT: UNKNOWN/ NOT PROVIDED. ASKU. SECTION B3: DATE OF EVENT: UNKNOWN, NOT PROVIDED. BEST ESTIMATE OF DATE OF EVENT IS BETWEEN SEPT. 28, 2022 AND FEB. 27, 2023. DEVICE EVALUATION: PRODUCT EVALUATION WAS NOT PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED. THE COMPLAINT ISSUE REPORTED COULD NOT BE CONFIRMED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING PROCESS RECORD WAS EVALUATED AND REVEALED THAT THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. THE SEARCH REVEALED ONE ADDITIONAL COMPLAINT FOLDER WAS RECEIVED FOR THIS PO. HOWEVER, COMPLAINT ISSUES REPORTED ARE NOT RELATED. THEREFORE, NO ESCALATIONS ARE REQUIRED. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. AN ATTEMPT HAS BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, NO DEFINITIVE RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION D9. DEVICE AVAILABLE FOR EVALUATION? YES. RETURNED TO MANUFACTURER ON: JUL. 18, 2023. SECTION H3. DEVICE EVALUATED MANUFACTURER? YES. DEVICE EVALUATION: TWO LENSES WERE RECEIVED FOR PI-0094172 AND PI-0094173. NO IDENTIFYING INFORMATION WAS RECEIVED WITH THE LENSES; THEREFORE, BOTH LENSES WILL BE EVALUATED IN BOTH PI'S. SAMPLE 1. VISUAL INSPECTION UNDER MAGNIFICATION REVEALED THAT THE COMPLAINT LENS WAS RECEIVED CUT BUT NOT SEPARATED AND THAT ONE HAPTIC WAS DETACHED. THE LENS WAS CLEANED AND, NO FURTHER ISSUES WERE OBSERVED. SAMPLE 2. VISUAL INSPECTION UNDER MAGNIFICATION REVEALED THAT THE COMPLAINT LENS WAS RECEIVED CUT BUT NOT SEPARATED. THE LENS WAS CLEANED AND, NO ISSUES THAT COULD CAUSE OR CONTRIBUTE TO THE COMPLAINT ISSUE COULD BE IDENTIFIED. THE COMPLAINT ISSUES WERE NOT CONFIRMED. THE OTHER OBSERVED ISSUE FOUND DURING THE PRODUCT EVALUATION COULD NOT BE CONFIRMED TO BE RELATED TO A MANUFACTURING OR DESIGN ISSUE. BASED ON THE COMPLAINT INVESTIGATION RESULTS, THE PRODUCT WAS RELEASED WITHIN SPECIFICATIONS. CONCLUSION: AS A RESULT OF THE INVESTIGATION THE COMPLAINT ISSUE REPORTED COULD NOT BE CONFIRMED AND NO PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION COULD BE IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT HAD HER BILATERAL INTRAOCULAR LENSES (IOLS) EXPLANTED BY ANOTHER SURGEON. PATIENT HAD BEEN EXPERIENCING GLARE AND HALOS, STARBURSTS AROUND LIGHTS AT NIGHT AND SPIKES AND ALL SORTS OF REFRACTION ISSUES AND EYESIGHT HAS DETERIORATED OVER TIME AND COULD NOT SEE 15 FEET IN FRONT OF HER. NIGHT DRIVING FROM GLARE IS BLINDING AND IMPOSSIBLE TO DRIVE AT NIGHT. ALL LIGHTS, HEADLIGHTS, TAILLIGHTS, STREETLIGHTS, HOUSE LIGHTS ALL HAD A COMBINATION OF HALOS, SPIRALS, STARBURSTS, AND FERRIS WHEELS. SOUTHERN EYE CENTER REMOVED BOTH IOLS RECENTLY. PATIENT IS LOOKING TO GET REIMBURSEMENT FROM PHYSICIAN BUT HAS NOT TOLD PHYSICIAN YET. IT WAS LEARNED THAT THE EXPLANTED IOLS WERE REPLACED WITH NON-JOHNSON AND JOHNSON IOLS. CUSTOMER SAID THAT HER VISION IS A LOT BETTER THAN WHEN SHE HAD THE OLD LENSES. CUSTOMER CONFIRMED THAT SHE HAS BOTH EXPLANTED IOLS WITH HER AND WILL GIVE THEM TO HER IMPLANT DOCTOR ONLY IF SHE WILL REIMBURSE HER WITH HER EXPENSES. OTHERWISE, SHE WILL NOT RETURN THE PRODUCTS FOR EVALUATION. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT CAPTURES EVENT FOR LEFT EYE. A SEPARATE REPORT IS SUBMITTED FOR THE OTHER EYE (RIGHT EYE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1186918 TECNIS IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO PUERTO RICO MFG. INC. DFR00V 05050474750678

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention