http://www.accessdata.fda.gov/scripts/c ... _ID=475323
THE INTRALASE FS LASER WAS USED TO CREATE THE CORNEAL FLAPS FOR BILATERAL LASIK SURGERY IN 2003. A 120 MICRON FLAP WAS CREATED WITH THE INTRALASE FS LASER, HOWEVER WHEN THE SURGEON ATTEMPTED TO LIFT THE FLAP (IN THE OS EYE) WITH A SLADE SPATULA, HE CREATED A FALSE CHANNEL WITH THE SPATULA. THE SURGEON THEN INTRODUCED THE SPALULA FROM THE OPPOSITE SIDE AND THE FLAP LIFTED SUCCESSFULLY AND THE EXCIMER TREATMENT WAS PERFORMED. AT THE ONE DAY POSTOP VISIT, THE PATIENT PRESENTED WITH FLAP EDEMA, HAZO, RIDGES, AND BLURRY VISION. THE PATIENT WAS RETERRED TO A CORNEAL SPECIALIST FOR POSTOPERATIVE FOLLOW-UP. AT THE ONE-MONTH POSTOPERATIVE VISIT. THE PATIENT'S BEST CORRECTED VISUAL ACUITY (DCVA) IN THE AFFECTED (OS) EYE WAS 20/200, COMPARED WITH THE PATIENT'S PREOPERATIVE BCVA OF 20/20).
http://www.accessdata.fda.gov/scripts/c ... _ID=474912
SUBSEQUENT TO LASIK SURGERY WITH USE OF THE INTRALASE FS LASER TO CREATE THE CORNEAL FLAP, A PATIENT PRESENTED WITH DIFFUSE LAMELLAR KERATATIS (DLK) BILATERALLY. AT APPROXIMATELY ONE WEEK POSTOPERATIVELY, THE DLK HAD PROGRESSED TO STAFE IV AND CENTRAL FOLDS WERE OBSERVED. THE PATIENT WAS TREATED WITH TOPICAL STERIODS; HOWEVER THE FLAPS WERE NOT LITTED OR RINSED. AT THE 3 WEEK POSTOPERATIVE VISIT, THE PATIENT'S BEST CORRECTED VISUAL ACUITY HAD DECREASED MORE THAN 2 LINES AND RESULTED IN INDUCED ASTIGMATISM.
http://www.accessdata.fda.gov/scripts/c ... _ID=474978
ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION
REPORT DATE: 07/02/2003 MDR TEXT KEY: 1646970 Patient Sequence Number: 1
THE INTRALASE FS LASER AND INTRALASE PATIENT INTERFACE WERE USED TO CREATE THE CORNEAL FLAPS FOR BILATERIAL LASIK SURGEON. DURING SURGERY ON TEH OS EYE, THE DISSECTION WAS INCOMPLETE AND RESULTED IN A TORN CORNEAL FLAP. THE INCOMPLETE DISSECTION WAS LATER ATTRIBUTED TO A BENT PATIENT INTERFACE CONE. THE LASIK SURGERY WAS THEN PERFORMED SUCCESSFULLY AND THE PATIENT'S BEST CORRECTED VISUAL ACUITY (BCVA) IN THE AFFECTED EYE WAS 20/25 AT THE ONE WEEK POSTOPERATIVE VISIT. THE PATIENT'S PREOPERATIVE BCVA WAS 20/20. ALL THE TIME OF THE COMPLAINT CLOSURE, THE PATIENT'S BCVA IMPROVED TO 20/20 AT THE 3 MONTH POSTOPERATIVE VISIT. 6 MONTHS LATER INTRALASE WAS NOTIFIED THAT THIS PATIENT HAD LASIK ENHANCEMENT PERFORMED ON BOTH EYES, THE ENHANCEMENT PROCEDURE WAS NOT PERFORMED AS A RESULT OF THE COMPLICATION. DURING THE ENHANCEMENT ON THE OS EYE, A 160-MICRON FLAP WAS CREATED WITH THE INTRALASE FS LASER. THE SURGEON OBSERVED GAS BUBBLES FORMING UNDER THE PREVIOUS FLAP, SO HE WAITED 5 HOURS AND THEN CRCATED A SECOND FLAP AT A DEPTN TO 200 MICRONS. THE FLAP WAS LIFTED SUCCESSFULLY AND THE EXCIMER ABLATION WAS PERFORMED. AT THE PATIENT'S MOST RECENT POSTOPERATIVE VISIT, THE BCVA IN OS EYE HAD DECREASED FROM 20/20 PREOPERATIVELY TO 20/50 AND IRREGULAR ASTIGMATISM WAS OBSERVED. THE SURGEON IS CONSIDERING PERFORMING A CUSTOM EXCIMER TREATMENT.
ADDITIONAL MANUFACTURER NARRATIVE
REPORT DATE: 07/02/2003 MDR TEXT KEY: 1646973
THE INIRALASE PATIENT INTERFACE CONE WAS RETURNED TO INTRALASE FOR EVALUATION. THE RESULTS OF THE INVESTIGATION REVEALED THAT THE CONE DID NOT MEET SPECIFICATIONS. ONE OF THE FOUR CONE LEGS WAS SLIGHTLY BENT.