The reference (b)(4) has been allocated to this case by rayner.The event description provided states that the patient's refractive outcome post-operatively was not as anticipated.The target outcome was -0.2 and the actual post-operative outcome is -1.There are many factors that may influence a post-operative refractive outcome including but not limited toincorrect product selection, aniseikonia combined with unsuitable lens power selection, wrong lens power causedby incorrect biometry readings/calculations (e.G., previous lasik procedure), surgically induced astigmatism,patient pre-existing medical history limiting ability for visual correction, patient not tolerating functional style of the lens, and lens rotation, decentration or tilt."deviation from target refraction"is listed in the "adverse events" section of the rayone ifu.There is currently insufficient information/evidence available to determine the cause of the deviation in the patient's post-operative refractive outcome.Rayner is following up with the healthcare facility to obtain additional information to facilitate further investigation of the event.
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