BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTACS PRESCRIPTION INSERTS

    MDR report key: 726921 · Received June 20, 2006

    Report

    Report Number
    2953726-2006-00006
    Event Type
    Injury
    Date Received
    June 20, 2006
    Date of Event
    April 18, 2006
    Report Date
    June 20, 2006
    Manufacturer
    ADDITION TECHNOLOGY, INC.
    Product Code
    LQE
    PMA / PMN Number
    H040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAFETY AND EFFICACY OF THE INTACS SURGICAL TECHNIQUE (P980031) WAS ESTABLISHED USING THE MANUAL INTACS SURGICAL INSTRUMENTS NOT THE INTRALASE LASER KERATOME (K001211). THE INTACS SEGMENT MAY HAVE BEEN IMPLEMENTED TOO SHALLOWLY AND/OR PLACED TOO CLOSE TO THE INCISION TO CREATE A NUTRITIONAL ISSUE FOR THE CORNEAL TISSUE IN THE INCISION AREA.

    Description of Event or Problem · 1

    ON APRIL 28, 2006 AN EVENT WAS REPORTED TO ADDITION TECHNOLOGY. THIS EVENT INVOLVED THE REMOVAL OF BOTH INTACS PRESCRIPTION INSERTS SEGMENTS ON APRIL 18,2006 FROM MT A MALE PATIENT ( AGE UNKNOWN) . THE INFERIOR INTACS SEGMENT (0.350 MM) WAS REMOVED DUE TO CORNEAL EROSION/MELTING IN THE INCISION AREA THAT WAS SECONDARY TO THE SEGMENT ROTATING BENEATH THE INITIAL INCISION AREA. THE INFERIOR INTACS SEGMENTS WAS EXPOSED AT THE TIME OF THE REMOVAL. DETAILS OF THE EVENT ARE PROVIDED BELOW: THE PATIENT HAD AN INTACS PROCEDURE FOR KERATOCONUS PERFORMED ON THE LEFT EYE ON JANUARY 5,2006 BY JACK WEISS, MD. AN INTRALASE LASER KERATOME WAS USED TO CREATE THE INCISION AT 35 DEGREES AND TO CREATE THE INTRASTROMAL TUNNEL FOR PLACEMENT OF THE INTACS SEGMENTS. TWO DIFFERENT THICKNESSES OF THE INTACS SEGMENTS (0.250MM AND 0.350MM) WERE IMPLANTED IN A SUPERIOR/INFERIOR ORIENTATION. THE PATIENT HAD NO REFRACTIVE TREATMENTS PERFORMED PRIOR TO THE INTACS PROCEDURE, NOR HAD THERE BEEN ANY SECONDARY REFRACTIVE PROCEDURES PERFORMED ON THE PATIENT. IT SHOULD BE NOTED THAT DR. WEISS USED AN INTRALASE LASER KERATOME TO CREATE THE INCISION AND THE INTRASTROMAL TUNNEL , INSTEAD OF THE MANUAL INTACS SURGICAL INSTRUMENTS THAT ARE USED FOR THE FDA-APPROVED SURGICAL TECHNIQUE FOR INTACS PRESCRIPTION INSERTS (PMA NO. P980031 AND HDE NO. H040002). WHILE INTRALASE CORPORATION HAS FDA CLEARANCE (K001211) FOR THE INTRALASE 600C LASER KERATOME FOR USE IN PERFORMING LAMELLAR CORNEAL RESECTIONS TO CREATE TUNNELS FOR PLACEMENT OF CORNEAL RING SEGMENTS, THE SAFETY AND EFFICACY OF THE INTACS SURGICAL TECHNIQUE WAS ESTABLISHED FOR PMA P980031 USING THE MANUAL INTACS SURGICAL INSTRUMENTS NOT THE INTRALASE 600C LASER KERATOME. THE PATIENT PRESENTED ON APRIL 18,2006 (APPROXIMATELY 3 MONTHS POST IMPLANT) COMPLAINING OF DISCOMFORT, REDNESS, BURNING AND DRYNESS IN HIS LEFT EYE. THE PATIENT STATED THAT THE SYMPTOMS HAD BEEN OCCURRING FOR APPROXIMATELY ONE WEEK PRIOR TO HIM COMING BACK TO THE DOCTOR FOR AN EVALUATION. UPON EXAMINATION , THE DOCTOR NOTED THAT THE INFERIOR INTACS SEGMENT (0.350MM) HAD ROTATED BENEATH THE INITIAL INCISION AREA AND THE CORNEAL MELTING /EROSION HAD OCCURRED SUCH THAT THE SEGMENT WAS EXPOSED. DR. WEISS IMMEDIATELY REMOVED BOTH INTACS SEGMENTS FROM THE PATIENTS CORNEA. THE PATIENT WAS LAST SEEN FOR A POST-REMOVAL EXAMINATION BY DR. WEISS ON MAY 12, 2006. THE PATIENT WAS STABLE AND HAS NOT EXPERIENCED ANY COMPLICATIONS OR SIGNIFICANT SEQUELAE AS A RESULT OF THE INTACS REMOVAL PROCEDURE. THE PATIENT HAD A TRACE AMOUNT OF OPACITY REMAINING IN THE WOUND AREA AT THE LAST EXAM

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTACS PRESCRIPTION INSERTS CORNEAL IMPLANTS LQE ADDITION TECHNOLOGY, INC. JCRS-250-150 B05A1016

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention