BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 11705131 · Received April 22, 2021

    Report

    Report Number
    2648035-2021-07655
    Event Type
    Injury
    Date Received
    April 22, 2021
    Date of Event
    June 1, 2020
    Report Date
    April 22, 2021
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE (YEAR): AVERAGE AGE 66. GENDER: 13 MEN, 33 WOMEN. WEIGHT & ETHNICITY: INFORMATION UNKNOWN, NOT PROVIDED. DATE OF EVENT: EXACT DATES NOT PROVIDED, ARTICLE ACCEPTANCE DATE IS JUN 1, 2020. SERIAL NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. A COMPLETE CATALOG NUMBER IS UNKNOWN AS THE SERIAL NUMBER WAS NOT PROVIDED. EXPIRATION DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. UDI NUMBER: A COMPLETE UDI NUMBER IS UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. IMPLANT DATE: UNKNOWN, INFORMATION NOT PROVIDED. EXPLANT DATE: UNKNOWN, INFORMATION NOT PROVIDED. MFR SITE PHONE NUMBER: (B)(4). DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. CITATION: MASKET, S., MD, RUPNICK, Z., MD, FRAM, R. N., MD, KWONG, S., BS, MCLACHLAN, J., BA, SURGICAL MANAGEMENT OF POSITIVE DYSPHOTOPSIA: U.S. PERSPECTIVE, J CATARACT REFRACT SURG. 2020; 46(11): PP.1474-1479. DEVICE EVALUATION: THE PRODUCT TESTING COULD NOT BE PERFORMED AS THE PRODUCT WAS NOT RETURNED. THE REPORTED COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD EVALUATION: THE MANUFACTURING RECORD REVIEW COULD NOT BE PERFORMED BECAUSE THE SERIAL NUMBER OF THE COMPLAINT PRODUCT IS UNKNOWN. SINCE THE SERIAL NUMBER IS UNKNOWN, THE COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED. CONCLUSION: SINCE THE SAMPLE OF THE COMPLAINT PRODUCT WAS NOT RETURNED, AND SERIAL NUMBER IS UNKNOWN, IT IS NOT POSSIBLE TO DETERMINE A MALFUNCTION AND/OR PRODUCT QUALITY DEFICIENCY. 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

    THE FOLLOWING ARTICLE WAS RECEIVED BASED ON A LITERATURE REVIEW: ARTICLE: SURGICAL MANAGEMENT OF POSITIVE DYSPHOTOPSIA: U.S. PERSPECTIVE. A NONRANDOMIZED RETROSPECTIVE STUDY WAS DONE TO EVALUATE CLINICAL OUTCOMES OF INTRAOCULAR LENS (IOL) EXCHANGE FOR INTOLERABLE POSITIVE DYSPHOTOPSIA (PD). A TOTAL OF 56 EYES OF 46 PATIENTS (N=37 EYES OF 30 PATIENTS WITH PD AND N=19 EYES OF 16 PATIENTS WITH PD AND ND) WERE INCLUDED IN THE STUDY. PATIENTS PREVIOUSLY IMPLANTED WITH ZCB00 (N=9), ZA9003 (N=2), ZMB00 (N=2), ZKB00 (N=1), ZXTXXX (N=1), AND ZXR00 (N=5) (JOHNSON & JOHNSON VISION) DEVELOPED POSITIVE DYSPHOTOPSIA. AS INTERVENTION, IOL EXCHANGE SURGICAL TREATMENT WAS PERFORMED WHICH INCLUDE BAG-TO-BAG PC IOL EXCHANGE, BAG-TO-SULCUS IOL EXCHANGE (INCLUDING CASES WITH IRIS SUTURE FIXATION [ISF] FOR STABILITY), AND REVERSE OPTIC CAPTURE (ROC) WITH IOL EXCHANGE. THIS REPORT IS FOR THE REPORTED ADVERSE EVENTS ON THE INTRAOCULAR LENS, MODEL ZMB00. SEPARATE REPORTS ARE BEING SUBMITTED TO CAPTURE THE REPORTED ISSUES ON THE OTHER INTRAOCULAR LENSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606562 TECNIS IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS ZMB00

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention