BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTACS PRESCRIPTION INSERTS

    MDR report key: 695276 · Received April 3, 2006

    Report

    Report Number
    2953726-2006-00001
    Event Type
    Injury
    Date Received
    April 3, 2006
    Date of Event
    March 14, 2006
    Report Date
    March 31, 2006
    Manufacturer
    ADDITION TECHNOLOGY, INC.
    Product Code
    LQE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IN 2006 AN EVENT WAS REPROTED TO ADDITION TECHNOLOGY. THIS EVENT INVOLVED THE REMOVAL OF ONE INTACS PRESCRIPTION INSERT FROM "R H-B", A FEMALE PATIENT (AGE UNK), DUE TO A CORNEAL MELT/EXPOSURE OF THE INTACS SEGMENT AROUND THE INITIAL INCISION AREA. THE PT HAD AN INTACS PRESCRIPTION INSERT PROCEDURE FOR KERATOCONUS PERFORMED IN 2005 BY MD. THE PT HAD NO PREIOR REFRACTIVE TREATMENTS. DR. USED AN INTRALASER 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 HAD 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 AND APPROVED BY FDA FOR PMA P980031 USING THE MANUAL INTACS SURGICAL INSTRUMENTS NOT THE INTRALASE 600C LASER KERATOME. THE PT PRESENTED IN 2006 (APPROX 11 MONTHS POST-IMPLANT) COMPLAINING OF DISCOMFORT IN HER LEFT EYET. UPON EXAMINATION, THE DOCTOR NOTED THAT AN EGDE OF THE INTACS SEGMENT (0.300 MM) WAS PROTRUDING THROUGH THE EPITHELIUM NEAR THE INCISION AREA. THE PT STATED THAT SHE HAD BEEN EXPERIENCING SOME DISCOMFORT FOR A WHILE, BUT HAD DELAYED COMING IN FOR AN EXAMINATION BECAUSE SHE LIVES SOME DISTANCE OUT OF TOWN. DR. IMMEDIATELY REMOVED THE EXPOSED INTACS SEGMENT FROM THE PT'S CORNEA. THE PT HAS NOT YET BEEN SEEN BY DR. FOR HER POST-REMOVAL EXAMINATION, BUT HTYE EXPECT TO EXAMINE THE PT WITHIN THE NEXT WEEK OR TWO. THERE HAVE BEEN NO CALLS THAT WOULD INDICATE THAT THE PT WAS EXPERIENCING ANY COMPLICATIONS AS A RESULT OF THE INTACS REMOVAL PROCEDURES. ADDITIONAL INFORMATION REGARDING THE EVENT: UPON INVESTIGATING THIS EVENT, ADDITION TECHNOLOGY DISCOVERED THAT THE PRODUCT (LOT NUMBER C99C1258) WAS ACTUALLY THREE YEARS BEYONG ITS LABELED EXPIRATION DATE AT THE TIME OF IMPLANT. ADDITION TECHNOLOGY HAD DISCUSSED THIS SITUATION WITH THE DOCTOR AND ADVISED AGAINST IMPLANTING PRODUCT THAT IS BEYOND ITS LABELED EXPIRATION DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTACS PRESCRIPTION INSERTS CORNEAL IMPLANT LQE ADDITION TECHNOLOGY, INC. ICRS-300-150 C99C125B

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention