[19495016]
The patient was scheduled to undergo lasik surgery in 2000. According to the medical records prepared by the treating physician, and a report of an april 23, 2002 examination of the patient by an independent physician reviewer, lasik was planned and performed only on the left eye in order to correct the patient's distance vision and a pre-existing astigmatism. After the corneal flap was made, the treating surgeon noticed an irregularity in the flap, known as a buttonhole. The treating surgeon laid the buttonhole flap back into position and ended the lasik procedure without carrying out any ablation. During the post-operative visit the day after the surgery, the treating surgeon noted the presence of folds in the superior part of the flap and apparently applied a weck-cel sponge and a bandage contact lens in order to correct the folds. Following this post-operative treatment, the patient complained of problems with their vision in the left eye. The patient then underwent a prk procedure apparently increased the astigmatism already present in the patient's left eye. Approximately five months later, in june 2001, the patient underwent an astigmatic keratotomy, with two cuts performed, in order to address the astigmatism. While the patient's vision improved with the astigmatic keratotomy, the independent medical reviewer diagnosed pt in april 2002 as still having an irregular astigmatism, left eye, due most likely to multiple refractive procedures. This combination of events induced some irregularities in the central cornea, according to the independent reviewer. While the independent reviewer found that the cornea was well healed, they determined that these irregularities were not amenable to complete correction based on current technology. Consistent with this diagnosis, the patient complains of night glare, halos, and ghost images, and their best corrected vision measures 20/25+ with two letters read on the 20/20 line of the eye chart. The reviewing physician thought pt's condition could be improved further, however, by the patient's use of a macro rigid permeable contact lens. To co's knowledge, the patient has not tried this option. Co has not reported this matter until now due to delays in receiving information about the patient's condition and uncertainty over the facts of the incident and the patient's additional refractive procedures. Monria learned generally of the patient's medical complaint through pt's initiation of litigation against the company in october 2001, but monria was only able to investigate the patient's condition through the process of evidentiary discovery conducted in the summer of 2002. In the litigation, the patient alleged that the irregular flap cut during the attempted lasik procedure was attributable to a defective moria blade. In support of this allegation, the patient referenced a product alert moria issued in december 2000 to remind surgeons to inspect blades carefully before performing lasik. Information on the product alert was provided to the fda under a separate report. To date, co has no reason to believe that a moria blade caused or contributed to the patient's alleged injuries. As noted, the patient underwent additional refractive procedures following the attempted lasik, and these procedures appear to have aggravated pt's condition. In addition, the standard treatment for addressing an imperfectly cut flap is to lay the flap down, apply a contact lens bandage (on the day of surgery, not the day after), and allow the flap to heal naturally. This standard was not observed in the current case, and there is some question as to whether the additional refractive procedures were medically necessary or desirable. Moreover, in november 2000, after receiving an oral report from the treating surgeon that he had cut a buttonhole flap on november 6, moria inspected the microkeratome console, as well as the heads, rings, turbine motor, and electrical motor. Each of these device components performed as desired, except that the electrical motor was thought to be operating a bit slowly and was exchanged to ensure continued optimal performance. No connection between the electrical motor and the patient's injury was ever established or even alleged as part of the patient's litigation. It is also clear if the actual blade used in the attempted lasik procedure was made available to co for inspection. Moria still does not have sufficient information to ascertain whether the patient has suffered a serious injury. Nor, for the reasons stated above, can moria determine whether medical or surgical intervention was necessary to preclude permanent damage or functional impairment, or whether the recurrence of a minor slow down in electrical motor speed would be likely to cause death or serious injury. Nonetheless, out of an abundance of caution, co has elected to file this report to inform the fda of these events.
Patient Sequence No: 1, Text Type: D, B5