BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_MULTIFOCAL IOL

    MDR report key: 13031150 · Received December 17, 2021

    Report

    Report Number
    3012236936-2021-00300
    Event Type
    Injury
    Date Received
    December 17, 2021
    Report Date
    January 28, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: IN FURTHER REVIEW OF THE FILE, IT WAS NOTED THAT THE INITIAL MDR SECTION G3 HAD THE INCORRECT DATE RECEIVED BY MANUFACTURE (20-NOV-2021). THE CORRECT DATE IS 19-NOV-2021. THE EMAIL WAS SENT ON 19-NOV-2021 (PACIFIC STANDARD TIME), BUT THE RECEIVED DATE REFLECTED CURRENT LOCAL TIME IN INDIA AS 20-NOV-2021. THEREFORE, IT IS CAPTURED IN THIS SUPPLEMENTAL REPORT. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: AGE AND DATE OF BIRTH, PATIENT WEIGHT, AND ETHNICITY AND RACE: UNKNOWN AS INFORMATION WAS NOT PROVIDED. DATE OF EVENT: UNKNOWN AS INFORMATION WAS NOT PROVIDED BUT THE BEST ESTIMATE DATE IS (B)(6) 2021. BRAND NAME: UNKNOWN AS INFORMATION WAS NOT PROVIDED. MODEL NUMBER: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. CATALOG NUMBER: A COMPLETE CATALOG NUMBER IS UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. DEVICE SERIAL NUMBER: UNKNOWN AS INFORMATION WAS NOT PROVIDED. EXPIRATION DATE: UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. UDI NUMBER: A COMPLETE UDI NUMBER IS UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. DATE IMPLANTED: UNKNOWN AS INFORMATION WAS NOT PROVIDED BUT THE BEST ESTIMATE DATE IS (B)(6)2021. DATE EXPLANTED: NOT APPLICABLE AS THE IOL REMAINS IMPLANTED. DEVICE SERIAL NUMBER IS NOT AVAILABLE AND THE IOL REMAINS IMPLANTED; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED. DEVICE MANUFACTURE DATE : UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT'S OCULAR DEXTER (RIGHT EYE). PATIENT COMPLAINED THAT HIS EYE HAS DETERIORATED SINCE HIS SURGERY 4 MONTHS AGO. HE HAS GONE BACK TO THE DOCTOR AND WAS TOLD THERE IS NOTHING WRONG. HIS EYE IS WORSE THAN IT¿S EVER BEEN; IT WAS NOT AS BAD AS BEFORE THE PROCEDURE. HIS EYE FEELS LIKE IT HAS PRESSURE IN IT, SHE DID AN ASTIGMATISM AND SHE STRETCHED THE EYE, AND IT FEELS LIKE THERE IS SOMETHING IN THERE ALL THE TIME. HE HAS HEARD GOOD THINGS ABOUT THE LENS, AND HE¿S NOT SAYING THE LENS IS THE ISSUE, BUT HE HAS NOT GOT FULL EFFECT LIKE HE WAS TOLD HE WOULD. HE PAID $3500 TO UPGRADE THE LENS AND IT¿S RUINED HIS EYE, HIS EYE IS SHOT. THE PATIENT IS UPSET, BECAUSE HIS DOCTOR HAS NOT SEEN HIM IN OVER THREE (03) WEEKS WHEN SHE KNOWS HE HAVING PROBLEMS WITH HIS EYE. HE IS SCHEDULED TO SEE A SPECIALIST (B)(6) 2022. THERE IS A FILM, ON THE BACK SIDE OF THE SAC AND THE DOCTOR DOES NOT KNOW WHAT TO DO WITH IT; SHE DOES NOT KNOW IF SHE SHOULD LASER IT, OR IF THE LENS WAS THE CORRECT LENS FOR HIS EYE. FROM THE FIRST DAY OF SURGERY, HE DID NOT GET GOOD RESULTS. HE WENT TO GET A SECOND OPINION AND THE DOCTOR SAID HE SAW 3 THINGS WRONG, BUT HE TOLD HIM TO GO BACK TO HIS ORIGINAL DOCTOR BECAUSE HE DOES NOT WANT TO TOUCH IT. THROUGH FOLLOW-UP, THE PATIENT ALSO REPORTED COMPLAINTS OF WATERY EYE, EYE FEELS SWOLLEN, BUT EYE DOES NOT LOOK SWOLLEN, AND THERE IS PAIN TRAVELING DOWN FACE AND NOW HIS UPPER TEETH ARE STARTING TO HURT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1927516 UNK_MULTIFOCAL IOL MULTIFOCAL IOLS MFK AMO PUERTO RICO MFG. INC. UNK-MULTIFOCAL IOL

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| O