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Contact Lens Informed Consent (ALL CL)

Contact Lens Informed Consent

1. Informed Consent for Medical Device Wear

Contact lenses are regulated by the FDA as Class II or III medical devices. Because they rest directly on the eye, they require professional oversight and strict adherence to care protocols to prevent sight-threatening complications.

Potential Risks & Complications:

  • Infections: Including microbial keratitis which can lead to permanent vision loss.
  • Corneal Damage: Abrasions, swelling (edema), or neovascularization (new blood vessel growth).
  • Inflammation: Internal eye inflammation or giant papillary conjunctivitis (GPC).
  • Discomfort: Dryness, debris accumulation, or reduced wearing time.


Alternative Vision Correction:

  • Spectacles: Eliminates the risk factors associated with contact lens wear.
  • Daily Disposables: Significantly safer than sleeping in lenses or multi-day replacement systems.
  • Refractive Surgery: A surgical option to reduce dependency on lenses, carrying its own set of risks.


Patient Emergency Protocol:
If you experience redness, pain, unusual light sensitivity, or sudden blurred vision, you must:

  1. Immediately remove the contact lenses.
  2. Contact our office or an emergency eye care provider.
  3. Do not re-insert lenses until cleared by a doctor.

Patient Acknowledgement & Signature

I certify that I have read this document, understand the risks, and have had my questions answered to my satisfaction. I agree to follow the wearing schedule and care instructions prescribed by my optometrist.

 
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