BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNFOLDER EMERALDAR INSERTION HANDPIECE

    MDR report key: 11631624 · Received April 7, 2021

    Report

    Report Number
    2648035-2021-07513
    Event Type
    Malfunction
    Date Received
    April 7, 2021
    Report Date
    August 18, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    KYB
    UDI-DI
    05050474502178
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: IN FURTHER REVIEW IT WAS DETERMINED THE SUSPECT PRODUCT SHOULD HAVE BEEN REPORTED AS THE EMERALDAR HANDPIECE AS THE PLUNGER CAUSED THE LENS DAMAGE. THEREFORE, THIS SUPPLEMENT WILL PROVIDE THE PRODUCT INFORMATION FOR THE HANDPIECE, SERIAL NUMBER (B)(6). AS PART OF CORRECTED DATA, BELOW SECTIONS WERE UPDATED: SECTION D1: BRAND NAME: UNFOLDER EMERALDAR INSERTION HANDPIECE SECTION D2: TYPE OF THE DEVICE: EMERALDAR HANDPIECE SECTION D2: DEVICE PRODUCT CODE: KYB. SECTION D4: MODEL NUMBER: EMERALDAR SECTION D4: CATALOG NUMBER: EMERALDAR SECTION D4: EXPIRATION DATE: UNKNOWN, INFORMATION NOT AVAILABLE. SECTION D4: SERIAL NUMBER: (B)(6). SECTION D4: UNIQUE IDENTIFIER (UDI) NUMBER: (B)(4). SECTION D10: CONCOMITANT MEDICAL PRODUCT: AR40E SN (B)(6) SECTION H4: DEVICE MANUFACTURE DATE: 5/28/2014. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: UPON FURTHER REVIEW OF THIS EVENT IT WAS NOTED THAT ADDITIONAL INFORMATION RECEIVED FROM THE SURGERY CENTER REVEALED THAT THERE WAS NO PATIENT CONTACT WITH THE LENS. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT IS NO LONGER CONSIDERED REPORTABLE AS THERE WAS NO PATIENT CONTACT WITH THE LENS. THEREFORE, NO FURTHER INFORMATION WILL BE SUBMITTED UNDER MEDWATCH 2648035-2021-07513. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    IF IMPLANTED, GIVE DATE: UNKNOWN, INFORMATION NOT PROVIDED. IF EXPLANTED, GIVE DATE: UNKNOWN, INFORMATION NOT PROVIDED. TELEPHONE NUMBER: (B)(6). ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, NO 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 DOCTOR BEFORE THE IMPLANTING OF THE INTRAOCULAR LENS (IOL) AND AFTER THE ADEQUATE MOUNTING, ACCORDING TO THE ROUTINE ORIENTED BY THE MANUFACTURER, IT WAS OBSERVED THAT THE SECOND HAPTIC OF THE IOL SUFFERED DEFORMATION CAUSED BY THE INJECTOR PISTON. THE IOL ISSUE WAS OBSERVED DURING HANDLING PRIOR TO INSERTION, NEVERTHELESS, WAS FULLY INSERTED. THE IMPLANT WAS IMMEDIATELY INTERRUPTED AND THE REPLACEMENT OF THE IOL AND CARTRIDGE WITH EQUIVALENT UNITS WERE REQUESTED AND IMPLANTED NORMALLY. NO OTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528004 UNFOLDER EMERALDAR INSERTION HANDPIECE EMERALDAR HANDPIECE KYB AMO PUERTO RICO MFG. INC. EMERALDAR 05050474502178

    Patients

    Seq Age Sex Outcome Treatment
    1 AR40E SN (B)(6).