BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS MULTIFOCAL TORIC II IOL

    MDR report key: 10946476 · Received December 4, 2020

    Report

    Report Number
    9614546-2020-00509
    Event Type
    Injury
    Date Received
    December 4, 2020
    Date of Event
    September 25, 2020
    Report Date
    January 22, 2021
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474689459
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D10: DEVICE AVAILABLE FOR EVALUATION: YES. SECTION D10: RETURNED TO MANUFACTURER ON: (B)(6) 2020. SECTION H3: DEVICE RETURNED TO MANUFACTURER: YES . DEVICE EVALUATION: THE COMPLAINT LENS WAS RECEIVED SUBMERGED IN AN UNKNOWN SOLUTION INSIDE A SPECIMEN CUP. ADDITIONAL DOCUMENTATION AND THE REPLACEMENT LENS¿ PATIENT STICKER WERE RECEIVED AS WELL. THE COMPLAINT LENS WAS CLEANED, AND VISUAL INSPECTION UNDER MAGNIFICATION WAS PERFORMED AND NO COSMETIC DEFECTS WERE OBSERVED. THE COMPLAINT ISSUE COULD NOT BE CONFIRMED, AND NO PRODUCT DEFICIENCY COULD BE IDENTIFIED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. THE SEARCH REVEALED ONE COMPLAINT FROM THIS PRODUCTION ORDER NUMBER, HOWEVER THE REPORTED ISSUE IS UNRELATED THIS REPORTED COMPLAINT AND NO PRODUCT DEFICIENCY WAS IDENTIFIED IN THAT CASE. 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

    (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTRAOCULAR LENS(IOL) WAS EXPLANTED FROM PATIENT'S LEFT EYE IN A SECONDARY SURGICAL PROCEDURE BECAUSE OF PATIENT HAVING BLURRY VISION. FIRST DAY FOLLOW UP VISIT AFTER IMPLANTATION OF LENS STATED THAT OS HAS BEEN A LITTLE ACHING VISION MORE BLURRY THAN OD WAS AND COMBO DRUG WAS PRESCRIBED 4 TIMES A DAY IN OPERATED EYE. THERE WAS NO DELAY IN PROCEDURE. SURGICAL INTERVENTIONS SUCH AS INCISION ENLARGEMENT AND SUTURES WERE PERFORMED BUT VITRECTOMY WAS NOT REQUIRED. THE REPLACEMENT LENS USED IS OF SAME MODEL BUT DIFFERENT DIOPTER. PATIENT/USER OUTCOME: VISUAL ACUITY POST-OP: NEAR 20/80, 20/30 DISTANCE. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1414191 TECNIS MULTIFOCAL TORIC II IOL TORIC IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. ZLU150 05050474689459

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention