USER MANUAL (Instruction for Use) SW 6.1
Introduction
Version 6.1.6 dated 2020-01-31 EN Page 45 of 201
3.3.4 Indirect Side Effects (caused by the complete surgery)
Flap Damage or Loss (LASIK only):
Instead of creating a hinged flap of tissue on the corneal shape, the entire flap could
come off. If this occurs it can be replaced after the laser treatment. However, there is
a risk that the flap could be damaged or lost.
Distorted Flap (LASIK only):
Irregular healing of the corneal flap could create a distorted corneal shape, resulting
in a decrease of best-corrected vision.
Side effects caused by the medication
Dry Eye Syndrome:
Postoperative dry eye due to damaging of nerves in the cornea during the flap cut or
epithelial removal. This syndrome may last up to three months.
Even when everything goes perfectly, there are effects that might cause some
dissatisfaction. Older patients should be aware that they can't have both good distance
vision and good near vision in the same eye without corrective lenses. Some myopic
patients rely on their myopia (by removing their glasses or by wearing a weaker
prescription) to allow them to read. Such a patient may need reading glasses after the
myopia is surgically corrected. Another consideration is the delay between eye
treatments. If one eye is being treated at a time, both eyes may not work well together
during the time between treatments. If a contact lens is not tolerated on the untreated
eye, work and driving may be awkward or impossible until the second eye has been
treated.
3.3.5 Residual Risks
Technical design and safety measures reduce any potential risk to an acceptable level and reduce
as far as possible following residual risks associated with potential harms and complications
caused by treatments using SCHWIND AMARIS product family lasers:
Risk of a disturbance of the fertility
Patient discontent
Loss of treatment quality (refractive outcome)
Incorrect treatment including insufficient clinical outcome, lost of visus, ablepsia
Overcorrection, undercorrection or decentration
Allergy
Burn, harm of the patient’s eye, retina or skin
Risk of infection
Contamination of environment like contamination with fluorine
Bodily harm of patient, user or third parties
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