BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 16379589 · Received February 15, 2023

    Report

    Report Number
    3012236936-2023-00348
    Event Type
    Injury
    Date Received
    February 15, 2023
    Date of Event
    December 13, 2022
    Report Date
    April 6, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474731813
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT IDENTIFIERS: INFORMATION UNKNOWN/NOT PROVIDED. IF IMPLANTED, GIVE DATE: UNKNOWN/NOT REPORTED: IT IS UNKNOWN IF THE IOL HAD ANY PATIENT CONTACT OR IF IT WAS IMPLANTED. IF EXPLANTED, GIVE DATE: UNKNOWN/NOT REPORTED: IT IS UNKNOWN IF THE IOL HAD ANY PATIENT CONTACT OR IF IT WAS IMPLANTED. 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 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

    ADDITIONAL INFORMATION: FOLLOW UP INFORMATION RECEIVED THAT THE SUSPECT LENS WAS NOT INSERTED, A BACK-UP LENS (B)(6), 22.0 DIOPTER POWER WAS USED INSTEAD, EYE AFFECTED IS RIGHT EYE (OD) HEALTH CARE PROFESSIONAL SURGEON IS DR. (B)(6). FIELD BELOW UPDATED. SECTION E1: COMPLAINT REPORTER FIRST NAME: (B)(6). SECTION E1: COMPLAINT REPORTER LAST NAME: (B)(6). SECTION E2: HEALTHCARE PROFESSIONAL : YES SECTION E3: OCCUPATION: PHYSICIAN. 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 WITH A WEAK CORNEA SPOT WITH AN INTRAOCULAR LENS (IOL) AND THE LENS DID NOT FIT. A VITRECTOMY WAS REQUIRED. PATIENT CONTACT WAS REPORTED AS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1140597 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474731813

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention