BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATHLETE I/A TIP 45 DEGREE TYPE

    MDR report key: 3191605 · Received June 26, 2013

    Report

    Report Number
    2020664-2013-00032
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    April 16, 2013
    Report Date
    May 29, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQC
    PMA / PMN Number
    K060366
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CHANGED TO UNKNOWN AS THE ACCOUNT REPORTED THAT DURING SURGERIES THEY USED SIX (6) ATHLETE I/A TIP 45 DEGREE TYPE MODEL OM0551021J AND THREE (3) PHACOFIT TITANIUM 0.3MM 45O SILICONE SLEEVE TIP MODEL OM05510116. DEVICES NOT RETURNED. ONLY PICTURES WERE PROVIDED BY THE CUSTOMER. ADDITIONAL INFORMATION: PRODUCT WAS NOT RETURNED AND PICTURES WERE PROVIDED BY THE CUSTOMER FOR BOTH TIP MODELS. ALL PICTURES WERE NOT FOCUSED OR CLEAR. WITHOUT A CHANCE TO EVALUATE THE ACTUAL TIPS THIS REPORT IS ALSO NOT ACCURATE. IN THE PHOTOS ALL TIPS SHOWS SIGNS OF USE SUCH AS SCRATCHES AND RESIDUE BUT APPEAR TO BE FREE OF BURRS. DUE TO POOR LIGHTING ON PHOTOS WE WERE UNABLE TO GET A CLEAR VIEW OF THE PORT CONDITION. DUE TO THE FACT THAT NO LOT NUMBERS WERE PROVIDED WE ARE UNABLE TO DETERMINE WHEN THESE TIPS MAY HAVE BEEN SHIPPED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER ONLY REQUESTED TO TAKE A PHOTO OF THE TIPS. THE PRODUCTS WERE PHOTOGRAPHED AND RETURNED TO THE CUSTOMER. CONCLUSION NOT YET AVAILABLE AS EVALUATION IS IN PROGRESS.NOTE: ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS AT THE TIME OF THIS REPORT HAS BEEN SUBMITTED. (B)(4): PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS AT THIS TIME HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE CUSTOMER REQUESTED TO HAVE ALL THE I/A TIPS PHOTOGRAPHED TO INSPECT FOR ANY PRESENCES OF DEFORMATION AT THE TIP SUCH AS BURRS (INFO SUBMITTED IN SUPPLEMENTAL #1 SHOWS THERE WAS NO BURRS IN THE PRODUCT). (B)(4).

    Additional Manufacturer Narrative · 1

    PLACEHOLDER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT POSTERIOR CAPSULE RAPTURE HAD OCCURRED DURING SURGERIES WHILE IRRIGATION/ASPIRATION WAS BEING APPLIED. SURGEON SAID THAT VITRECTOMY WAS PERFORMED BUT PATIENT HEALTH WAS NOT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290680 ATHLETE I/A TIP 45 DEGREE TYPE PHACO ACCESSORIES HQC ABBOTT MEDICAL OPTICS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ALCON INFINITY PHACO MACHINE (UNK SERIAL NUMBER)