BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 16190207 · Received January 17, 2023

    Report

    Report Number
    3012236936-2023-00088
    Event Type
    Injury
    Date Received
    January 17, 2023
    Date of Event
    December 22, 2022
    Report Date
    January 17, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474636132
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE WAS NOT RETURNED AT THE MANUFACTURING SITE; 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 OF COMPLAINTS 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. ATTEMPTS HAVE BEEN MADE TO OBTAIN THE MISSING INFORMATION. HOWEVER, TO DATE IT 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 IOL (INTRAOCULAR LENS) WAS INSERTED AND THEN REMOVED DUE TO THE PATIENT'S WEAK ZONULES. THE LENS WAS REPLACED WITH A NON J&J IOL. REPORTEDLY, IT'S UNKNOWN IF THE WEAK ZONULES WERE PRE-EXISTING. THERE WERE NO OTHER INJURIES OR MEDICAL INTERVENTION REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1541 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00 05050474636132

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention