BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 11742668 · Received April 28, 2021

    Report

    Report Number
    2648035-2021-07665
    Event Type
    Malfunction
    Date Received
    April 28, 2021
    Date of Event
    March 29, 2021
    Report Date
    June 17, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474619920
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE PRODUCT TESTING COULD NOT BE PERFORMED AS THE PRODUCT WAS NOT RETURNED. THE REPORTED COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD EVALUATION: BASED ON THE MANUFACTURING RECORDS REVIEW, AND HISTORICAL COMPLAINT REVIEW, THERE IS NO INDICATION OF A PRODUCT MALFUNCTION OR PRODUCT QUALITY DEFICIENCY. NO NONCONFORMITY REPORT, DOCUMENTATION OR LABELING CHANGES, AND ESCALATIONS ARE REQUIRED. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    AGE, WEIGHT AND ETHNICITY: UNKNOWN/ NOT PROVIDED. EXPLANT DATE: NOT APPLICABLE, AS LENS WAS NOT EXPLANTED. INITIAL REPORTER TELEPHONE NUMBER: (B)(6). AN ATTEMPT HAS BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PLASTIC RESIDUAL WHICH ENTERED THE EYE WITH THE PCB00 LENS AT IMPLANT. SURGEON THOUGHT IT CAME OFF FROM THE PCB00 INJECTOR. THE MATERIAL WAS REMOVED WITH IRRIGATION ASPIRATION (I/A). THERE WAS NO INDICATION OF FURTHER INTERVENTION. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632695 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. PCB00 05050474619920

    Patients

    Seq Age Sex Outcome Treatment
    1