BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SULCOFLEX

    MDR report key: 4911673 · Received July 8, 2015

    Report

    Report Number
    9611165-2015-00030
    Event Type
    Injury
    Date Received
    July 8, 2015
    Report Date
    July 8, 2015
    Manufacturer
    RAYNER INTRAOCULAR LENSES LTD.
    Product Code
    HQL
    PMA / PMN Number
    P060011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REFERENCE (B)(4) HAS BEEN ALLOCATED TO THIS CASE BY RAYNER. LIGHT MICROSCOPY REVEALED THE PRESENCE OF GRANULAR DEPOSITS IN THE AREA OF GROSS WHITE DISCOLORATION, DENSELY DISTRIBUTED IN AN OVERALL ROUND PATTERN WITH VERY DISTINCT MARGINS. THE GRANULES WERE PRESENT ON THE ANTERIOR SURFACE/SUBSURFACE OF THE IOL. SCANNING ELECTRON MICROSCOPY AND EDS OF THE SULCOFLEX IOL CONFIRMED THAT THE COMPOSITION OF THE DEPOSITS WAS PRIMARILY CALCIUM AND PHOSPHATE. THE AUTHORS STIPULATE THAT THE CAUSE OF THE PARTICULAR PATTERN OF CALCIFICATION THEY OBSERVED ON THE LENS COULD BE A COMBINATION OF TWO MECHANISMS: (1) THE PRESENCE OF EXOGENOUS AIR OR GAS IN THE EYE MAY CAUSE A METABOLIC CHANGE IN THE ANTERIOR CHAMBER, INITIATING CALCIFICATION. (2) EXACERBATED AND/OR PROLONGED RUPTURE OF BLOOD-AQUEOUS BARRIER WITH AN INFLAMMATORY REACTION IS USUALLY ASSOCIATED WITH MULTIPLE SURGICAL PROCEDURES AND MAY ALSO INCREASE THE CHANCES OF CALCIFICATION. A COPY OF THE FULL PAPER IS ENCLOSED FOR REFERENCE PURPOSES. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    A REPORT OF IOL OPACIFICATION INVOLVING A RAYNER SULCOFLEX IOL WAS IDENTIFIED WITHIN THE "CALCIFICATION OF HYDROPHILIC ACRYLIC INTRAOCULAR LENSES ASSOCIATED WITH INTRACEMERAL AIR INJECTION FOLLOWING DMEK' PAPER PUBLISHED IN THE JOURNAL OF CATARACT AND REFRACTIVE SURGERY. THE PAPER READS: "THE PATIENT WAS AN (B)(6) WOMAN WITH A HISTORY OF CORNEAL SCARRING FOLLOWING PTERYGIUM SURGERY AND IRRADIATION TRAUMA TO THE LEFT EYE. THIRTY YEARS AFTER SURGERY AND TRAUMA, AS A RESULT OF THE CORNEAL SCARRING, PENETRATING KERATOPLASTY (PKP) WITH SIMULTANEOUS CATARACT EXTRACTION AND IOL IMPLANTATION (MODEL 68UV +23.5 DIOPTERS (D), STORZ OPHTHALMICS) HAS BEEN PERFORMED IN THE LEFT EYE. TWELVE YEARS AFTER THE PKP AND CATARACT SURGERY, A SULCOFLEX PIGGYBACK IOL (RAYNER INTRAOCULAR LENSES LTD) WAS INSERTED IN THE LEFT EYE BECAUSE OF A REFRACTION OF +5.75-4.50 X 55. ONE MONTH AFTER IMPLANTATION, THE CORRECTED DISTANCE VISUAL ACUITY (CDVA) WAS 6/6 (+0.25D). APPROXIMATELY 1 YEAR LATER, THE ORIGINAL CORNEAL GAFT IN THE LEFT EYE FAILED AND A DMEK PROCEUDRE WAS PERFORMED. THE CDVA IMPROVED FROM (B)(6) TO (B)(6) AFTER DMEK. THE NEW GRAFT WAS RE-BUBBLED (AIR) TWICE OVER THE FIRST POSTOPERATIVE MONTH. AT 5 MONTHS, SLIGHT HAZE WAS NOTICED ON THE ANTERIOR SURFACE OF THE PIGGYBACK IOL. THE CORNEAL GRAFT WAS NOTED TO BE WELL FUNCTIONING. AT 1 YEAR, THE CDVA HAD DECREASED MILDLY ((B)(6)) AND THE PATIENT REPORTED A "SMEAR" OVER HER VISION. DURING THE EXAMINATION, IT WAS ALSO NOTED THAT THE HAZE HAD INCREASED OVER THE ANTERIOR SURFACE OF THE PIGGYBACK IOL. THE CORNEAL GRAFT WAS AGAIN NOTED TO BE NORMAL. A MONTH LATER, THE PIGGYBACK IOL WAS EXPLANTED AND SENT FOR ANALYSIS. THE PATIENT WAS GIVEN UPDATED GLASSES AND REPORTED MORE CLARITY IN HER VISION, THE CDVA WAS 6/6".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441809 SULCOFLEX HQL RAYNER INTRAOCULAR LENSES LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention SECONDARY IOL IMPLANTATION (SULCOFLEX),| DMEK,| RE-BUBBLING OF CORNEAL GRAFT,| PKP, CATARACT EXTRACTION AND IOL IMPLANTATION,| PTERYGIUM SURGERY,