BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTEC HD

    MDR report key: 4539360 · Received February 24, 2015

    Report

    Report Number
    9613160-2015-00002
    Event Type
    Injury
    Date Received
    February 24, 2015
    Report Date
    March 6, 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

    THE LITERATURE REPORTS EXPLANT IN 2012 AND IS CONFIRMED BY SURGEON IN 2015 REPORT TO LENSTEC. IN THIS CASE, THE PATIENT HAD DSEK OR DSAEK TWO MONTHS AFTER CATARACT SURGERY. THE OPACIFICATION APPEARED RELATIVELY FAST AFTER THE LAST PROCEDURE REQUIRING INTRACAMERAL INJECTION OF AIR/GAS. THE IOL OPACIFICATION WAS CLINICALLY OBSERVED ON THE ANTERIOR OPTIC SURFACE WITHIN THE VISUAL AXIS, LEADING TO A DECREASE IN VISUAL ACUITY AND COMPLAINTS OF "FOGGY" VISION PROMPTING EXPLANTATION AND IOL EXCHANGE. THE PATIENT PRESENTED WITH FUCH'S DYSTROPHY PREOPERATIVELY REQUIRED A GRAFT AND REBUBBLING OCCURRED; THE LENS WAS RETURNED IN A LENS CASE. NO LENSTEC PACKAGING WAS RECEIVED. A VISUAL INSPECTION WAS CARRIED OUT ON THE DEVICE USING THE STEREOSCOPIC MICROSCOPE. THE DEVICE WAS RETURNED WITH A JAGGED BREAK EXTENDING APPROXIMATELY 3/4 WAYS ACROSS THE OPTIC. THERE WAS ALSO THE PRESENCE OF SMALL BUMPS (OPACIFICATION) IN THE CENTER OF THE OPTIC AND AT THE EDGE OF THE OPTIC WHERE IT MEETS THE HAPTIC. THE LENS WAS CLEANED WITH A SWAB AND PURIFIED WATER. THE RESULTS OF THE CLEANING AND INSPECTION REVEALED THAT THE OPACIFICATION WAS NOT REMOVED. THE OPACIFICATION WAS SUPERFICIAL ONLY WHEN INSPECTED FROM THE CROSS SECTION PERSPECTIVE, NO IN DEPTH OPACIFICATION WAS IDENTIFIED IN THE LENS. AN ALIZARIN RED 1% DYE TEST WAS PERFORMED IN ORDER TO DETERMINE WHETHER THE LENS COULD HAVE BEEN CONTAMINATED WITH DEPOSITS OF CALCIUM ON THE SURFACE. THE RESULTS WERE NEGATIVE FOR TRACES OF CALCIUM. NOTE THE STAINING WAS NOT INITIALLY COMPLETED AFTER EXPLANT AND AS THE MANUFACTURER ONLY BECAME AWARE IN 2015, THE STORAGE CONDITIONS OF THE LENS ARE UNKNOWN. A FULL AUDIT OF ALL BATCH DOCUMENTATION RELATING TO THE PRODUCTION OF THE LENS WAS PERFORMED. THE AUDIT CONCLUDED THAT ALL PROCEDURES IN MANUFACTURING AND PACKAGING OF THE LENS HAD BEEN CONDUCTED CORRECTLY. BATCH RECONCILIATION WAS 100.0%.BASED ON THE ASSESSMENT OF OUR BATCH DOCUMENTATION, LENSTEC CAN CONFIRM THAT ALL PROCEDURES IN THE MANUFACTURING AND PACKAGING OF THE LENS WERE CONDUCTED CORRECTLY. MICROSCOPIC EXAMINATION OF THE LENS INDICATED THAT THE OPACIFICATION WAS SUPERFICIAL, IT DID NOT EXTEND THROUGH THE MATRIX OF THE LENS AND IT DID NOT STAIN FOR CALCIUM. WE CAN FIND NO EVIDENCE TO SUGGEST THAT THERE IS ANY FAULT IN THE MANUFACTURED LENS THAT WOULD HAVE BROUGHT RISE TO THIS OPACIFICATION. ADDITIONALLY, LENSTEC BELIEVES THAT THE LENS, ITS DESIGN AND THE MANUFACTURING PROCESS ARE NOT AT FAULT DUE TO THE EXTENSIVE TESTING THAT WE HAVE PERFORMED ON THIS MODEL. FURTHERMORE, LENSTEC CAN CONFIRM THAT WE HAVE NEVER HAD ANY CONFIRMED LENS-RELATED CASES OF OPACIFICATION FOR OUR HEMA LENSES. WITH REGARDS TO THE OPTIC, LENSTEC CONCLUDES THAT THIS WAS PROBABLY CUT TO FACILITATE REMOVAL OF THE LENS FROM THE EYE. WE NOW CONSIDER THIS COMPLAINT CLOSED PENDING ANY FURTHER INFORMATION ON THIS CASE.

    Description of Event or Problem · 1

    AFTER A LITERATURE REVIEW OF JOURNAL OF CATARACT & REFRACTIVE SURGERY 2015; 41:199-207, ARTICLE TITLED "LOCALIZED OPACIFICATION OF HYDROPHILIC ACRYLIC INTRAOCULAR LENSES AFTER PROCEDURES USING INTRACAMERAL INJECTION OF AIR OR GAS" IDENTIFIED A LENSTEC SOFTEC (MODEL NOT IDENTIFIED IN ARTICLE) INTRAOCULAR LENS THAT WAS EXPLANTED DUE TO OPACIFICATION. LENSTEC HAS CONTACTED THE PAPER AUTHOR TO FACILITATE THE RETURN OF THE IOL FOR INVESTIGATION AND TO OBTAIN INFORMATION ON THE EXPLANTING PHYSICIAN FOR PATIENT CONDITION AND HISTORY. LENSTEC HAS SINCE RECEIVED THE IOL AND IT IS UNDER INVESTIGATION. ONCE THE LENS INVESTIGATION AND INFORMATION FROM EXPLANTING PHYSICIAN IS RECEIVED LENSTEC WILL SUBMIT A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THIS IS A SUPPLEMENTAL REPORT TO THE FOLLOWING: AFTER A LITERATURE REVIEW OF JOURNAL OF CATARACT & REFRACTIVE SURGERY 2015; 41:199-207, ARTICLE TITLED "LOCALIZED OPACIFICATION OF HYDROPHILIC ACRYLIC INTRAOCULAR LENSES AFTER PROCEDURES USING INTRACAMERAL INJECTION OF AIR OR GAS" IDENTIFIED A LENSTEC SOFTEC (MODEL NOT IDENTIFIED IN ARTICLE) INTRAOCULAR LENS THAT WAS EXPLANTED DUE TO OPACIFICATION. LENSTEC HAS CONTACTED THE PAPER AUTHOR TO FACILATATE THE RETURN OF THE IOL FOR INVESTIGATION AND TO OBTAIN INFORMATION ON THE EXPLANTING PHYSICAN FOR PATIENT CONDITION AND HISTORY. LENSTEC HAS SINCE RECIEVED THE IOL AND THE INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128500 SOFTEC HD SOFTEC HD HQL LENSTEC BARBADOS INC. SOFTEC HD F2635

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention