Description of Event or Problem · 1
ON MARCH 2006 AN EVENT WAS REPORTED TO ADDITION TECHNOLOGY. THIS EVENT INVOLVED THE REMOVAL OF THE INTACS PRESCRIPTION INSERT FROM "MP", A MALE PATIENT (AGE UNKNOWN0, DUE TO THE INCISION "SPLAYING" OPEN. THE INTACS SEGMENT HAD ROTATED BENEATH THE WOUND AREA AND MOST LIKELY CAUSED THE INCISION TO RE-OPEN. DETAILS OF THE EVENT ARE PROVIDED BELOW. THE PATIENT HAD AN INTACS PRESCRIPTION INSERTS PROCEDURE FOR KERATOCONUS PERFORMED ON DECEMBER 2005 BY JACK WEISS, MD. THE PATIENT HAD NO PRIOR REFRACTIVE TREATMENTS DR. USED AN INTRALASE LASER KERATOME TO CREATE THE INCISION AND THE INTRASTROMAL TUNNEL INSTEAD THE MANUAL INTACS SURGICAL INSTRUMENTS THAT ARE USED FOR THE FDA APPROVED SURGICAL TECHNIQUE FOR INTACS SURGICAL INSTRUMENTS THAT ARE USED FOR THE FDA-APPROVED SURGICAL TECHNIQUE FOR INTACS PRESCRIPTION INSERTS (PMA NO P980031 AND HED 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 FOR 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 MARCH 24, 2006 (APPROXIMATELY 3 MONTHS POST-IMPLANT) COMPLAINING OF A FOREIGN BODY SENSATION IN HIS LEFT EYE. UPON EXAMINATION, THE DOCTOR NOTED THAT THE INTACS SEGMENT (0.350 MM) HAD ROTATED IN THE INTRASTROMAL TUNNEL TO BE IN THE INCISION AREA AND THAT THE INCISION HAD "SPLAYED" OPEN. IMMEDIATELY REMOVED THE INTACS SEGMENT FROM THE PATIENT'S CORNEA. THE PATIENT WAS SCHEDULED TO BE SEEN FOR HIS POST-REMOVAL EXAMINATION BY DR. IN MARCH 2006. THERE HAVE BEEN NO CALLS THAT WOULD INDICATE THAT THE PATIENT WAS EXPERIENCING ANY COMPLICATIONS AS A RESULT OF THE INTACS REMOVAL PROCEDURE.