BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FS DISPOSABLE INTERFACE

    MDR report key: 14317460 · Received May 7, 2022

    Report

    Report Number
    3012236936-2022-01215
    Event Type
    Malfunction
    Date Received
    May 7, 2022
    Date of Event
    September 17, 2020
    Report Date
    June 27, 2022
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    GEX
    UDI-DI
    15050474534688
    PMA / PMN Number
    K060372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PT. INFO.: UNKNOWN/ NOT PROVIDED. (B)(6). 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 05/05/2022. SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES. SECTION H6: INVESTIGATION FINDINGS 4247 - BASED ON THE INVESTIGATION, IT IS NOT BELIEVED THAT THIS IS A DESIGN OR PROCESS ISSUE, BUT MORE LIKELY A HANDLING OR OTHER IMPACT EVENT THAT HAS LED TO THE PACKAGING BEING PUNCTURED. DEVICE EVALUATION: ONE (1) OPENED PATIENT INTERFACE WAS RECEIVED WITHIN ORIGINAL PACKAGING CONFIRMING THE REPORTED LOT NUMBER. A VISUAL INSPECTION OF THE RETURNED PRODUCT REVEALED A SMALL, SEE-THROUGH PUNCTURE ON THE TYVEK LID. THE REPORTED ISSUE IS CONFIRMED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE DEVICE WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. CONCLUSION: ALTHOUGH THE REPORTED ISSUE WAS CONFIRMED, IT IS NOT BELIEVED THAT THIS IS A DESIGN OR PROCESS ISSUE, BUT MORE LIKELY A HANDLING OR OTHER IMPACT EVENT THAT HAS LED TO THE PACKAGING BEING PUNCTURED. THE QUANTITY OF THESE DEFECTS IS SMALL AND AS SUCH IT IS DETERMINED THAT PACKAGING UNDER NORMAL USE CONDITIONS IS SUFFICIENT AND MEETS DESIGN INTENT. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TYVEK LID OF THE PATIENT INTERFACE HAD A SMALL PINHOLE PUNCTURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1253192 FS DISPOSABLE INTERFACE POWERED LASER SURGICAL INSTRUMENT GEX AMO MANUFACTURING USA, LLC 590106AN 60231271 15050474534688

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown FEMTO LASER SN (B)(6)