BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTEC 1

    MDR report key: 4495756 · Received February 6, 2015

    Report

    Report Number
    9613160-2015-00001
    Event Type
    Injury
    Date Received
    February 6, 2015
    Report Date
    January 21, 2015
    Manufacturer
    LENSTEC BARBADOS, INC.
    Product Code
    HQL
    PMA / PMN Number
    P090022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER A LITERATURE REVIEW IDENTIFIED A CASE STUDY REPORTED DURING THE SEPTEMBER ESCRS AS A POSTER TITLED "INTRAOCULAR LENS OPACIFICATION AFTER DESCEMET'S STRIPPING AUTOMATED ENDOTHELIAL KERATOPLASTY (DSAEK)", LENSTEC BEGAN TO INVESTIGATE THE CLAIMS FOR COMPLAINT AND MDR REPORTABILITY. INTERNALLY, THIS BECAME COMPLAINT (B)(4) AS COMMUNICATION WITH THE AUTHORS WAS SOUGHT FOR MORE INFO. THE RETROSPECTIVE CASES INVOLVE PTS WHO BOTH REC'D CATARACT SURGERY AND A HAVE FUCH'S DYSTROPHY PEROPERATIVELY. THERE ARE 5 PTS IN TOTAL. CLINICAL INFO IS DIFFICULT TO OBTAIN AS THESE PTS WERE REFERRED FROM OTHER UNITS, PER DR. AMIT PATEL, ONE AUTHOR OF THE IDENTIFIED POSTER. FUCH'S DYSTROPHY IS KNOWN TO EVENTUALLY LEAD TO A CORNEAL TRANSPLANT DUE TO ENDOTHELIAL DECOMPENSATION, AND THUS PTS WOULD UNDERGO THE DSAEK PROCEDURE, ESSENTIALLY PROVIDING A GRAFTED SECTION OF REPLACEMENT CORNEA. THERE WAS A STATISTICALLY SIGNIFICANT ASSOCIATION BETWEEN DSAEK PERFORMED ON PTS WITH FUCHS ENDOTHELIAL DYSTROPHY AND IOL OPACIFICATION (AHAD AM, DARCY K, COOK SD ET AL INTRAOCULAR LENS OPACIFICATION AFTER DESCEMET STRIPPING AUTOMATED ENDOTHELIAL KERATOPLASTY. CORNEA. 2014; 33:1307-1311). IT HAS BEEN REPORTED IN LITERATURE THAT THE AIR BUBBLING USED IN THE PROCEDURE HAS A CORRELATION TO THE FORMATION OF AN ANTERIOR IOL OPACIFICATION. THE UNDERLYING MECHANISM REMAINS UNCLEAR; HOWEVER, BREAK DOWN OF THE BLOOD AQUEOUS BARRIER AND GAS/AIR IN THE ANTERIOR CHAMBER HAVE BEEN IMPLICATED AS POSSIBLE CAUSES (NEUHANN IM, NEUHANN, ROHRBACH JM. INTRAOCULAR LENS CALCIFICATION AFTER KERATOPLASTY. CORNEA. 2013; 32:E6-E10). TELEPHONE COMMUNICATION FOLLOWED UP BY EMAIL CONTACT WITH DR AMIT PATEL, AN AUTHOR OF THE RETROSPECTIVE STUDY POSTER, INDICATED THAT OF THE 5 SOFTEC CASES ALL HAD DSAEK AND 4/5 HAD A SECONDARY REBUBBLING PROCEDURE, HOWEVER ALL 5 CASES ARE BEING MONITORED AS THEY REMAIN SATISFIED WITH THEIR CURRENT LEVEL OF VISION. LITERATURE SUGGESTS THAT THE MAJOR IDENTIFIABLE RISK FACTOR OF DEVELOPING IOL OPACIFICATION WAS REBUBBLING OF DETACHED GRAFTS AND AFTER SERIAL PHOTOGRAPHY AND CLINICAL EXAMINATIONS SHOWED THAT AFTER INITIAL DEVELOPMENT, OVER TIME, THERE WAS LITTLE CHANGE IN THE LEVEL OF OPACIFICATION (AHAD AM, DARCY K, COOK SD ET AL. INTRAOCULAR LENS OPACIFICATION AFTER DESCEMET STRIPPING AUTOMATED ENDOTHELIAL KERATOPLASTY. CORNEA. 2014; 33:1307-1311). NONE OF THESE LENSES HAVE BEEN EXPLANTED TO DATE. LENSTEC CANNOT IDENTIFY THE ACTUAL LENSES IN QUESTION AS THEY REMAIN IMPLANTED AND ARE UNABLE TO VERIFY ANY SERIAL NUMBERS AS THE POSTER WAS WRITTEN BY THE NON-IMPLANTING PHYSICIAN. IF ANY ADD'L INFO BECOMES AVAILABLE AN ADD'L REPORT WILL BE FILED. LENSTEC IS UNABLE TO COMMENT ON THE NATURE OF THE OPACIFICATION. FURTHERMORE, WE CANNOT MAKE A DEFINITIVE CONCLUSION AS TO THE CAUSE OF THE OPACIFICATION AS THE LENSES REMAIN IMPLANTED. IF THE SURGEON DECIDED TO EXPLANT THE LENSES, THESE CAN BE FORWARDED TO LENSTEC FOR INSPECTION. HOWEVER, LENSTEC BELIEVES THAT THE LENS, ITS DESIGN AND THE MFG PROCESS ARE NOT AT FAULT DUE TO THE EXTENSIVE TESTING THAT WE HAVE PERFORMED ON THIS MODEL. ADDITIONALLY, BASED ON THE COMPLAINT HISTORY, LENSTEC CAN CONFIRM THAT WE HAVE NEVER HAD ANY CONFIRMED LENS-RELATED CASES OF OPACIFICATION FOR OUR HEMA LENSES.

    Description of Event or Problem · 1

    THE EVENT DESCRIPTION SUBMITTED BY RAYNER TO FDA STATED: "FIVE PTS (3 MALE, 2 FEMALE) WERE IDENTIFIED TO HAVE DEVELOPED IOL OPACIFICATION AFTER DSAEK SURGERY, WITH AVERAGE AGE OF 75.8 YRS (RANGE 71-81). ALL PTS UNDERWENT DSAEK FOR CORNEAL DECOMPOSITION SECONDARY TO FUCHS' ENDOTHELIAL DYSTROPHY AND HAVE REC'D HYDROPHILIC ACRYLIC IOL MODELS DURING THE PRIOR CATARACT SURGERY, INCLUDING 4 WITH SOFTEC 1 (LENSRTEC, (B)(4)) AND 1 WITH 570C (RAYNER INTRAOCULAR LENSES LTD). ALL PTS HAVE DEVELOPED A CENTRAL CRYSTALLINE OPACIFICATION ON THE ANTERIOR ASPECT OF THE IOL, OCCURRING BETWEEN 5 MONTHS AND UP TO 6 YRS AFTER DSAEK SURGERY". (SOURCE" INTRAOCULAR LENS OPACIFICATION AFTER DECEMET'S STRIPPING AUTOMATED ENDOTHELIAL KERATOPLASTY (DSAEK). AUTHORS: P/ MORGAN-WARREN AND A. PATEL). THE PAPER CITED WERE WAS FROM A POSTER SESSION AT THE 2014 ESCRS CONVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88141 SOFTEC 1 INTRAOCULAR LENS HQL LENSTEC BARBADOS, INC. SOFTEC 1

    Patients

    Seq Age Sex Outcome Treatment
    1