BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNFOLDER PLATINUM 1 SERIES

    MDR report key: 13637018 · Received March 1, 2022

    Report

    Report Number
    3012236936-2022-00514
    Event Type
    Malfunction
    Date Received
    March 1, 2022
    Date of Event
    January 19, 2022
    Report Date
    June 5, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    KYB
    PMA / PMN Number
    K081545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT RECEIVED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE/LOT HISTORY RECORD AND COMPLAINT TRENDING FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. AN ATTEMPT HAS 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: UPON FURTHER REVIEW, IT WAS NOTED THAT NEW INFORMATION WAS RECEIVED WITH PRODUCT INVESTIGATION. DATE OF BIRTH (DOB): [ILLEGIBLE MONTH] (B)(6) AND GENDER: MALE. THEREFORE, FIELD BELOW UPDATED. SECTION A3: GENDER: MALE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION D9. DEVICE AVAILABLE FOR EVALUATION? YES. RETURNED TO MANUFACTURER ON: MAY 2, 2022. SECTION H3. DEVICE EVALUATED MANUFACTURER? YES. DEVICE EVALUATION: VISUAL INSPECTION UNDER MAGNIFICATION REVEALED THAT THE CARTRIDGE WAS RECEIVED WITH A BENT CARTRIDGE TIP. DAMAGE AND A HOLE IN THE CARTRIDGE, CONSISTENT WITH A CARTRIDGE PUNCTURED BY A PLUNGER ROD, COULD BE IDENTIFIED JUST BELOW THE CARTRIDGE TIP AS WELL. NO FURTHER ISSUES THE COMPLAINT ISSUE OF "DC-CARTRIDGE TIP CRACKED/DAMAGED" WAS IDENTIFIED DURING PRODUCT EVALUATION; HOWEVER, THE COMPLAINT ISSUE COULD NOT BE CONFIRMED TO BE RELATED TO THE MANUFACTURING OR DESIGN PROCESS. 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 · 0

    CORRECTED DATA: UPON FURTHER REVIEW IT WAS NOTED THAT IN THE INITIAL REPORT SUBMITTED, SECTION D4: CATALOG NUMBER: WAS LEFT BLANK AND EXPLAINED IN H10 TEXT AS "SECTION D4: CATALOG NUMBER: UNKNOWN, AS THE LOT NUMBER WAS NOT PROVIDED" .HOWEVER, THESE WERE INCORRECT SINCE PARTIAL INFORMATION ON CATALOG NUMBER WAS PROVIDED TO BE 1MTEC.THIS SUPPLEMENTAL IS BEING SUBMITTED TO CORRECT THIS INFORMATION. FIELD BELOW UPDATED ACCORDINGLY. SECTION D4: ADDITIONAL DEVICE INFORMATION: CATALOG NUMBER: 1MTEC30. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CUSTOMER HAD AN ISSUE WITH OUR PRODUCTS. ISSUE WAS THAT THE CARTRIDGE TIP WAS BROKEN. THEN THEY REPLACED THE CARTRIDGE AND LENS. IT WAS STATED THAT THERE WAS PATIENT CONTACT. NO OTHER INFORMATION WAS PROVIDED DESPITE FOLLOW-UPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1173063 UNFOLDER PLATINUM 1 SERIES LENS, GUIDE, INTRAOCULAR KYB AMO PUERTO RICO MFG. INC. 1MTEC30 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male ZXR00 SN (B)(6).