USER MANUAL (Instruction for Use) SW 6.1
Introduction
Version 6.1.6 dated 2020-01-31 EN Page 43 of 201
3.3 Contraindications and Side Effects
Below you will find the list of contraindications and possible side effects for refractive photo
ablation. However, this list does not release you from the duty to update your own expertise with
the latest results from general research in the area of refractive surgery. Review all
contraindications according to the relevant literature and the national legislation.
Be sure to fully inform your patient about the risks and benefits of laser surgery during a
consultative conversation.
3.3.1 Absolute Contraindications for Refractive Photo Ablation
Unstable refraction.
In pregnant or nursing women.
In patients with signs of keratoconus or abnormal corneal topography.
In patients with collagen vascular, autoimmune or immunodeficiency diseases.
Severe local infective or allergic conditions (e.g. Blepharitis, Previous Herpes
Simplex or Zoster keratitis, Allergic eye disease severe enough to require regular
treatment).
Severe dry eye disease (minor dry eyes are not a contraindication).
Monocularity or severe amblyopia.
Cataract
In patients who are taking one or both of the following medications: isotretinoin
(Accutane
®
) or amiodarone hydrochloride (Cordarone
®
).
Other disease patterns determined by the ophthalmologist and/or surgeon to be
contraindications.
3.3.2 Relative Contraindications
Glaucoma
Diabetes Mellitus
Inappropriate motivation or unreasonable expectation
Other disease patterns determined by the ophthalmologist and/or surgeon to be
contraindications.
Age limit (patients should be older than 18 years old).
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