BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYNERGY SIMPLICITY TORIC II

    MDR report key: 12236569 · Received July 28, 2021

    Report

    Report Number
    9614546-2021-07275
    Event Type
    Injury
    Date Received
    July 28, 2021
    Date of Event
    June 28, 2021
    Report Date
    September 21, 2022
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474710320
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: AN EMPTY LENS BOX WITHOUT AN IMPLANTER SYSTEM AND IOL WAS RECEIVED. ADDITIONAL ANALYSIS IS NOT POSSIBLE. MANUFACTURING RECORD EVALUATION: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH REVEALED THAT NO ADDITIONAL/SIMILAR (AS APPLICABLE) COMPLAINTS FOR THIS ORDER NUMBER HAVE BEEN RECEIVED. BASED ON THE MANUFACTURING RECORDS REVIEW AND HISTORICAL COMPLAINT REVIEW, THERE IS NO INDICATION OF A PRODUCT MALFUNCTION OR PRODUCT QUALITY DEFICIENCY. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THE COMPLAINT CANNOT BE CONFIRMED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: SECTION H6: AS PART OF AN INTERNAL REVIEW OF OUR MDRS IT WAS IDENTIFIED THAT THE CODE 4631 PROVIDED ON THE INITIAL REPORT NEEDS TO BE CORRECTED. THE CORRECT H6: HEALTH EFFECT IMPACT CODE IS 4627. ALSO, FOR CODE 2330 PROVIDED IN THE INITIAL REPORT SHOULD ACTUALLY BE 4582 FOR H6: HEALTH EFFECT CLINICAL CODE. THIS REPORT IS SUBMITTED TO CORRECT THESE. FIELD BELOW UPDATED. H6: HEALTH EFFECT IMPACT CODE: 4627 (TO CAPTURE REMOVAL). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    AGE, WEIGHT, ETHNICITY: INFORMATION UNKNOWN NOT PROVIDED. IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS THE LENS WAS INSERTED AND REMOVED. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THE LENS WAS INSERTED AND REMOVED. INITIAL REPORTER :(B)(6). TELEPHONE: (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2021, A MODEL DFW100 PRELOADED SYSTEM WAS USED FOR INTRAOCULAR LENS (IOL) IMPLANT SURGERY ON THE PATIENT¿S LEFT EYE. THE PLUNGER-PISTON OF THE INJECTOR CAME OVER THE LENS DURING THE IMPLANTATION PROCESS AND SCRATCHED THE LENS. THE SURGEON DECIDED TO REMOVE THE LENS FROM THE EYE AND USE THE STANDBY LENS. HOWEVER, DURING USE BUT BEFORE IMPLANTATION, THE SURGEON NOTICED AGAIN WITH THE STANDBY LENS, THAT THE PLUNGER (PISTON) OF THE INJECTOR HAD ALREADY PUSHED ITSELF OVER THE LENS DURING PREPARATION. THEREFORE, THE SURGEON STOPPED THE OPERATION FOR THIS EYE. THE SURGEON WENT AHEAD AND OPERATED ON THE OTHER EYE (RIGHT EYE) WITH NO REPORTED ISSUES, AND NEW LENSES WERE FOR SURGERY TO BE COMPLETED THE NEXT DAY ON THE FIRST EYE. NO VITRECTOMY WAS NECESSARY, AND NO OTHER INTERVENTIONS WERE MENTIONED. THROUGH FOLLOW UP IT WAS LEARNED THAT THE SECOND LENS (STANDBY LENS) ATTEMPTED DID NOT HAVE CONTACT WITH THE PATIENT'S EYE. THE PATIENT SUCCESSFULLY UNDERWENT ANOTHER OPERATION TO IMPLANT A NEW INTRAOCULAR LENS IN THE LEFT EYE ON (B)(6) 2021. ON (B)(6) 2021 THE PATIENT REPORTED HE WAS HAPPY WITH HIS SIGHT AND HIS OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED. THE PATIENT REPORTED THAT THE ADDITIONAL OPERATION WAS PERFORMED ON THE LEFT EYE THE FOLLOWING DAY, REQUIRING ADDITIONAL ANESTHESIA AND WOUND CARE. DURING FOLLOW-UP CHECKS ON (B)(6) 2021 AND (B)(6) 2021 IT WAS SHOWN THAT THE LEFT EYE WAS STILL IRRITATED COMPARED TO THE RIGHT EYE THAT WAS ALSO TREATED AND IS SLIGHTLY BELOW THE RIGHT EYE IN TERMS OF VISUAL PERFORMANCE. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1139574 TECNIS SYNERGY SIMPLICITY TORIC II LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DFW100 05050474710320

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention