A FIELD SERVICE ENGINEER (FSE) PERFORMED AN ON-SITE EXAMINATION OF THE VISUMAX LASER KERATOME. THE FSE CONFIRMED THAT THE INSTRUMENT WAS WITHIN SPECIFICATIONS FOR ALL PARAMETERS. A REVIEW OF THE INSTRUMENT LOG FILES FOUND NO ISSUES RECORDED DURING THE PROCEDURE. A MANUFACTURER'S REPRESENTATIVE REVIEWED THE PATIENT'S PROCEDURE VIDEO PROVIDED BY THE SITE. THE ASSESSMENT WAS THE TREATMENT PACK WAS NOT CENTERED PRECISELY. THE INSTRUCTIONS FOR USE STATE: "28. POSITION THE PATIENT'S EYE ... SO THAT THE VISUAL AXIS IS EXACTLY IN THE CENTER OF THE CONTACT GLASS", "29. ... CAUTION ... "TAKE SPECIAL CARE TO ENSURE EXACT ALIGNMENT OF THE PATIENT'S EYE" AND "30. FINAL CHECK: CHECK AGAIN FOR PROPER CENTERING AND SUCTION." THE ASSESSMENT ALSO CONFIRMED THE PRESENCE OF AN OPAQUE BUBBLE LAYER (OBL) FORMATION BETWEEN 9 AND 10 O'CLOCK AS A RESULT OF THE PROCEDURE. THE FOLLOWING SIDE EFFECTS THAT MAY ARISE ARE IDENTIFIED IN THE INSTRUCTIONS FOR USE: "SIDE EFFECTS ... OTHER COMPLICATIONS ... INCOMPLETE INCISIONS" AND "SIDE EFFECTS ... TEMPORARY LIMITATIONS ... TEMPORARY GAS BUBBLES IN THE CORNEA." SITE CONTACT: SITE CONTACT IDENTICAL TO INITIAL REPORTER.
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Patient 1
IT WAS REPORTED THAT DURING A VISION CORRECTION SURGERY, THE SURGEON HAD DIFFICULTY LIFTING THE CORNEAL FLAP CREATED BY THE VISUMAX LASER KERATOME DUE TO AN OPAQUE BUBBLE LAYER (OBL). THE OBL WAS OUTSIDE OF THE PATIENT'S VISUAL AXIS. THE SURGEON MADE THE DECISION TO AMPUTATE THE FLAP. THE SURGEON ALSO MADE THE DECISION TO IMPLEMENT A PRK PROCEDURE FOR VISION CORRECTION INSTEAD OF THE PLANNED LASIK PROCEDURE. THE PATIENT'S POST-SURGICAL VISUAL ACUITY WAS 20/30 AT FIVE DAYS. NO ERROR MESSAGES OR ABNORMALITIES WERE OBSERVED BY THE SURGEON. THE VISUAMX LASER KERATOME WAS SUBSEQUENTLY USED ON TWO PATIENTS WITHOUT INCIDENT.