[19152489]
In december 2004, patient served a lawsuit against moria, inc ("moria") alleging injuries arising from various surgical procedures that took place between 2001 and 2003. Allegaions do not disclose which procedure(s) caused her alleged injuries. In addition, patient has not determined whether any moria equipment was used in any of the procedures. The lawsuit has essentially been stalled since its inception and moria has not yet had an opportunity to conduct an independent medical examination. Additionally, despite its many efforts, moria has been unable to depose patient or any of the medical professionals involved with patient's surgical procedures. Even though moria does not have sufficient information to ascertain whether the patient has suffered serious injury, out of an abundance of caution, moria has elected to file this report of inform the fda of the allegatins contained in patient's first amended complaint. Patient had bilateral lasik surgery in 2001. The physician first performed the lasik procedure on patient's right eye without any complications. The physician then began the procedure on the left eye and allegedly "severely abrad(ed) the cornea". According the patient, the physician then used a "tweezer type instrument and attempted to raise the remaininig part of the hinge to complete" the procedure. When that failed, the physician aborted the procedure. According to patient, the abrasion led to scarring, posterior vitreous separation, vision loss, and increased headaches. Patient underwent a photorefractive keratectory ("prk") procedure on her left eye in 2002. Following that surgery, patient's vision allegedly worsened and she experienced severe blurring. At a follow-up examination, a different physician informed her that the prk result was unpredictable and resulted from her flap not being perfectly smooth when the prk was performed. At that time, her vision was 20/100, but could be corrected with glasses to 20/25 with astigmatism. Patient alleges that her right eye developed floaters (small specks or coulds moving in the field of vision) as a result of 2002 prk procedure on her left eye. In 2003 patient underwent a third procedure. Like the second procedure, the third was a photorefractive keratectomy. According to patient the third procedure resulted in her experiencing "white flashes in her right eye in the dark" and her left eye "continues to be severely blurred and painful". In addition, she suffers from headaches, dizziness, upset stomach. In her first amended complaint, patient alleges that the procedures caused a "severe corneal abrasion with a large partial flap tear with multiple jaggged torn edges resulting in terrible scarring, and residual damage to the left eye, with posterior vitreous separation. " patient also alleges that her vision loss in her left eye has strained and diminished her vision in her right eye. According to the produced medical records, patient's best corrected vision in her left eye following the procedures is 20/30. She also has an increased astigmatism and scarring in the left eye that could be causing blurred vision. Without an independent medical examination, however, moria is unable to determine at this time whether patient's alleged injuries qualify as a "serious injury". Moreover, it is unknown whether patient's injuries arose from her first, second, or third procedures, or some combination thereof. Patient alleges that moria was negligent with respect to "certain vision equipment used during the eye surgeries/enhancements" of patient but has not been able to identify which moria equipment, if any, was used in her procedures or th ebasis for the claim that the equipment was the cause of any alleged injuries. Moreover, second and third procedures were prk and moria equipment is not used in those procedures. Accordingly moria cannot be responsible for any injuries that allegedly occurred as a result of either prk procedure. To date, moria has no reason to believe that a moria blade or microkeratome caused or contributed to the patient's alleged injuries. The microkeratome was never taken out of service and no problems were ever reported to moria. Moreover, counsel for the doctor that performed the procedure(s) has informed moria's counsel that moria's products did not cause patient's alleged injury. The foregoing information below is based solely on patient's allegations and a review of the medical records provided by patient that was conducted in 2005. Moria expressely reserves the right to supplement and/or modify the statements contained in this report as more information is learned about the veracity of patient's allegations and moria's alleged involvement,if any.
Patient Sequence No: 1, Text Type: D, B5