BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 20726981 · Received November 19, 2024

    Report

    Report Number
    3012236936-2024-000294
    Event Type
    Injury
    Date Received
    November 19, 2024
    Report Date
    November 26, 2024
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474560000
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D9. DEVICE AVAILABLE FOR EVALUATION? YES RETURNED TO MANUFACTURER ON: NOV. 13, 2024 SECTION H3. DEVICE EVALUATED MANUFACTURER? YES DEVICE EVALUATION: VISUAL INSPECTION WAS PERFORMED ON THE SUSPECT PRODUCT AND FOUND THE PLUNGER ROD WAS PARTIALLY ADVANCED. VISCOELASTIC RESIDUE WAS OBSERVED DISTRIBUTED THROUGH THE ENTIRE LENGTH OF THE LENS WAS CUT AND COATED IN VISCOELASTIC RESIDUE. THE LENS WAS CLEANED AND INSPECTED REVEALING SCRATCHES ON THE LENS. NO FURTHER EVALUATION WAS PERFORMED. THE COMPLAINT ISSUES REPORTED WERE NOT IDENTIFIED DURING PRODUCT EVALUATION. THE OTHER OBSERVED ISSUES DURING THE PRODUCT EVALUATION COULD NOT BE CONFIRMED TO BE RELATED TO THE MANUFACTURING OR DESIGN PROCESS. BASED ON THE COMPLAINT INVESTIGATION RESULTS, THE PRODUCT WAS RELEASED WITHIN SPECIFICATIONS. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION COULD BE IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION B3: DATE OF EVENT: UNKNOWN, NOT PROVIDED. BEST ESTIMATE OF DATE OF EVENT IS BETWEEN APR 17, 2024 AND OCT 17, 2024. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, THE INFORMATION HAS NOT BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO WRONG POWER. NO OTHER REASON FOR EXPLANT WAS SPECIFIED. THE REPLACEMENT LENS WAS OF THE SAME MODEL IOL BUT ONLY 0.5 HIGHER DIOPTER POWER THAT THE ORIGINAL IOL. THERE WAS NO OTHER MEDICAL OR SURGICAL INTERVENTION. NO PATIENT INJURY. THE PATIENT OUTCOME IS UNKNOWN. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2008357 TECNIS IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS ZKB00 05050474560000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention