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 INTRACAMERAL AIR INJECTION FOLLOWING DMEK' PAPER PUBLISHED IN THE JOURNAL OF CATARACT AND REFRACTIVE SURGERY. THE PAPER READS: "THE PT WAS AN (B)(6) WOMAN WITH A HISTORY OF CORNEAL SCARRING FOLLOWING PTERYGIUM SURGERY AND IRRADIATION TRAUMA TO THE LEFT EYE. THIRTY YEARS AFTER THE 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 HAD 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 GRAFT IN THE LEFT EYE FAILED AND A DMEK PROCEDURE WAS PERFORMED. THE CDVA IMPROVED FROM 6/24 TO 6/12 AFTER DMEK. THE NEW GRAFT WAS A 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 (6/18) AND THE PT 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 PT WAS GIVEN UPDATED GLASSES AND REPORTED MORE CLARITY IN HER VISION; THE CDVA WAS 6/6". PLEASE REFER TO RAYNER'S MDR 9611165-2015-00030 FOR FURTHER INFO.