BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 7115305 · Received December 13, 2017

    Report

    Report Number
    9614546-2017-01225
    Event Type
    Injury
    Date Received
    December 13, 2017
    Date of Event
    August 29, 2017
    Report Date
    March 26, 2018
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    UDI-DI
    05050474553941
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: FURTHER INFORMATION WAS PROVIDED AND REPORTED THAT SINCE IOL EXCHANGE, VISION IS BETTER WITH THIS LENS, I DO NOT SEE THE SPOTS. DYSPHOTOPSIA WAS DESCRIBED AS ''DIRTY VISION LIKE LOOKING THROUGH DIRTY SINK WATER'' AND ''SPOTS THAT MOVE WITH EYE''. PATIENT COMPLAINED BITTERLY STARTING IMMEDIATELY AFTER CATARACT SURGERY ON (B)(6) 2017, WITH THE LENS WHICH WAS WELL CENTERED IN THE BAG AND ON AXIS. IOL EXCHANGE PERFORMED ON (B)(6) 2017, JUST SHORT OF THREE MONTHS SINCE ORIGINAL SURGERY OS, LEFT EYE. VISUAL ACUITY PRE-OPERATIVELY? -3.0 +3.5 X 180 20/25 GLARE 20/400, VISUAL ACUITY POST-OPERATIVELY? -1.25 20/60. DATE OF BIRTH: (B)(6), GENDER/SEX: FEMALE. DATE OF EVENT: (B)(6) 2017. (B)(6), HEALTH PROFESSIONAL: YES, OCCUPATION: PHYSICIAN. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION? YES. RETURNED TO MANUFACTURER ON: 01/02/2018. DEVICE RETURNED TO MANUFACTURER? YES. DEVICE EVALUATION: THE SAMPLE WAS RETURNED TO THE MANUFACTURER. VISUAL INSPECTION WAS PERFORMED AND THE PRODUCT WAS CUT IN HALF, MOST PROBABLY TO MAKE THE EXPLANT POSSIBLE. CONSIDERING THE CONDITION OF THE LENS, FURTHER ANALYSIS WAS NOT POSSIBLE. THE COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD REVIEW: MANUFACTURING RECORD REVIEW OF THE PRODUCTION ORDER AND RELATED DOCUMENT REVEALED THAT THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. THERE WAS NO DISCREPANCY FOUND DURING THE REVIEW. A SEARCH REVEALED THAT NO SIMILAR COMPLAINTS WERE RECEIVED FOR THIS PRODUCTION ORDER. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS FOR THE PROPER USE AND HANDLING OF THE PRODUCT. CONCLUSION: BASED ON THE INVESTIGATION RESULTS 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

    DATE OF EVENT: UNKNOWN, NOT PROVIDED, BUT THE BEST ESTIMATE DATE IS BETWEEN (B)(6) 2017. (B)(4). ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TECNIS TORIC INTRAOCULAR LENS (MODEL ZCT400, +21.5 DIOPTER) WAS EXPLANTED IN SECONDARY SURGERY BECAUSE OF THE PATIENT COMPLAINING OF DYSPHOTOPSIA. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893989 TECNIS TORIC IOLS HQL ABBOTT MEDICAL OPTICS ZCT400 05050474553941

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention