Description of Event or Problem · 1
ON APRIL 28, 2006 AN EVENT WAS REPORTED TO ADDITION TECHNOLOGY. THIS EVENT INVOLVED THE REMOVAL OF ONE INTACS. CORNEAL IMPLANT SEGMENT ON MAY 5, 2006 FROM "SC", A MALE PT (AGE UNK). THE INFERIOR INTACS SEGMENT (0.350 MM) WAS REMOVED DUE TO SLIGHT CORNEAL EROSION IN THE INCISION AREA THAT WAS SECONDARY TO THE SEGMENT ROTATING BENEATH THE INITIAL INCISION AREA. THE INTACS SEGMENT WAS EXPOSED AT THE TIME OF THE REMOVAL. DETAILS OF THE EVENT ARE PROVIDED BELOW: THE PATIENT HAD AN INTACS PROCEDURE FOR KERATOCONUS PERFORMED ON THE RIGHT EYE ON JANUARY 23,2006 BY JACK WEISS, MD. AN INTRALASE LASER KERATOME WAS USED TO CREATE THE INCISION AT 165 AND TO CREATE THE INTRASTROMAL TUNNEL FOR PLACEMENT OF THE INTACS SEGMENTS. TWO DIFFERENT THICKNESSES OF THE INTACS SEGMENTS (0.250 MM AND 0.350 MM) WERE IMPLANTED IN A SUPERIOR/INFERIOR ORIENTATION. THE PATIENT HAD NO REFRACTIVE TREATMENTS PERFORMED PRIOR TO THE INTACS PROCEDURE, NOR HAD THERE BEEN ANY SECONDARY REFRACTIVE PROCEDURES PERFORMED ON THE PATIENT. IT SHOULD BE NOTED THAT DR. WIESS USED AN INTRALASE LASER 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 CORNEAL IMPLANTS (PMA NO. P980031 AND HDE NO. H040002). WHILE INTRALASE CORPORATION HAS 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 FOR PMA P980031 USING THE MANUAL INTACS SURGICAL INSTRUMENTS NOT THE INTRALASE 600C LASER KERATOME. THE PATIENT PRESENTED ON MAY 5,2006 (APPROXIMATELY POST IMPLANT) COMPLAINING OF IRRITATION, REDNESS, TEARING AND SWOLLEN LIDS IN HIS RIGHT EYE. THE PATIENT STATED THAT THE SYMPTOMS HAD BEEN OCCURRING FOR APPROXIMATELY ONE WEEK PRIOR TO HIM COMING BACK TO THE DOCTOR FOR AN EVALUATION. UPON EXAMINATION, THE DOCTOR NOTED THAT THE INTACS SEGMENT (0.350 MM) HAD ROTATED IN THE INTRASTROMAL TUNNEL TO BE BENEATH THE INITIAL INCISION AREA AND THAT A SLIGHT AMOUNT OF CORNEAL EROSION HAD OCCURRED. DR WEISS IMMEDIATELY REMOVED THE 0.350 MM INTACS SEGMENT FROM THE PATIENT'S CORNEA. THE PATIENT REMAINS IMPLANTED WITH THE 0.250 MM INTACS SEGMENT.THE PATIENT WAS LAST SEEN FOR A POST-REMOVAL EXAMINATION BY DR. WEISS ON MAY 12,2006. THE PATIENT WAS STABLE AND HAS NOT EXPERIENCED ANY COMPLICATIONS AS A RESULT OF THE INTACS REMOVAL PROCEDURE. THE PT STILL HAD A SMALL LINEAR DEFECT REMAINING OVER THE THE WOUND HOWEVER; THERE WAS NO EVIDENCE OF ANY INFILTRATES OR OTHER SEQUELAE AT THIS EXAM.