BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 16036374 · Received December 22, 2022

    Report

    Report Number
    3012236936-2022-03015
    Event Type
    Injury
    Date Received
    December 22, 2022
    Report Date
    February 6, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MJP
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT WEIGHT: UNKNOWN/NO INFORMATION. ETHNICITY: UNKNOWN/NO INFORMATION. RACE: UNKNOWN/NO INFORMATION. DEVICE AVAILABLE FOR EVALUATION? YES. DATE RETURNED TO MANUFACTURER: NOV 7, 2022. EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: VISUAL INSPECTION UNDER MAGNIFICATION WAS PERFORMED AND THE LENS WAS OBSERVED TO BE CUT, NOT SEVERED, BUT IS CONSISTENT WITH A LENS THAT WAS EXPLANTED. NO ISSUES RELATED TO THE COMPLAINT ISSUE WERE OBSERVED. A PRODUCT QUALITY DEFICIENCY COULD NOT BE DETERMINED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH REVEALED THAT NO OTHER COMPLAINTS WERE RECEIVED FOR THIS PRODUCTION ORDER. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ATTEMPTS HAVE BEEN MADE TO OBTAIN THE MISSING INFORMATION. HOWEVER, TO DATE IT HAS NOT BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC., HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: UPON FURTHER REVIEW IT WAS FOUND IN THE PATIENT IMPLANT CARD THAT IMPLANT DATE WAS CONFIRMED TO BE ON (B)(6) 2022. THEREFORE, THIS SUPPLEMENTAL REPORT IS SUBMITTED TO INDICATE THIS. FIELD BELOW UPDATED. SECTION D6A: IF IMPLANTED, GIVE DATE: ON (B)(6) 2022. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SURGEON HAD AN EYHANCE TORIC INTRAOCULAR LENS (IOL) PLACED AT 88 DEGREES WITH A POST-OP ON TARGET OUTCOME OF 87 DEGREES. THE PATIENT¿S ISSUE POST OP WAS THAT SHE WAS HAVING MAJOR GHOSTING/DOUBLE VISION OF IMAGES IN HER OPERATIVE EYE. HER UNCORRECTED VISION WAS ABOUT 20/30 AND THE DOCTOR COULD REFRACT HER TO 20/20 -2 WITH A -0.50. HOWEVER, THE GHOSTING IMAGE/LETTERS DID NOT RESOLVE. ADDING CYLINDER TO THE REFRACTION DID NOT IMPROVE THE GHOSTING OR THE BEST CORRECTIVE VISUAL ACUITY (BCVA). EVERYTHING ELSE LOOKED OKAY WITH THE PATIENT¿S EYE. DOCTOR FELT THE GHOSTING IS LIKELY DUE TO THE IOL ITSELF. THE DOCTOR PLANNED ON EXPLANT OF THIS IOL DIU150 AND REPLACING IT WITH AN ASTIGMATISM CORRECTION LENS DCU150 OF THE SAME POWER AS HE WANTS TO ENSURE THE GHOSTING IS NOT FROM THE EYHANCE TECHNOLOGY. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARN THAT THE LENS WAS EXPLANTED. HOWEVER, THE DETAILS OF THE NEWLY IMPLANTED LENS WERE NOT PROVIDED. NO FURTHER INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1406558 TECNIS IOL LENS, INTRAOCULAR, TORIC OPTICS MJP AMO PUERTO RICO MFG. INC. DIU150

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention