Calaview Etafilcon a Soft Hydrophilic Contact Lens for Daily Wear

FDA-Cleared Indications

• Daily-wear vision correction in patients with refractive errors.
• Use as a soft hydrophilic contact lens when prescribed and fitted by an eye-care professional.

Clinical Applications

• Correction of nearsightedness or farsightedness during daily wear.
• Temporary vision correction without eyeglasses.
• Daily contact-lens wear following professional fitting and prescription.
• Replacement of an existing soft contact lens when the prescribed material and design are appropriate.

Reported off-label uses

• Bandage-lens use to protect the cornea after selected surface procedures or injuries.
• Therapeutic use for selected corneal epithelial disorders under ophthalmic supervision.

Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.

Practical Considerations

• The lens must be fitted for the individual eye; parameters may include base curve, diameter and refractive power.
• It is intended for daily wear, not overnight or extended wear unless the specific labeling and eye-care professional expressly permit it.
• Wash and dry hands before handling, use only the recommended disinfecting or storage solution, and do not use water or saliva.
• Contact-lens wear is contraindicated or may require caution in active eye infection, significant ocular inflammation, severe dry eye or inability to follow lens-care instructions.
• A contact lens is not an implanted device and does not require MRI precautions; it should generally be removed before MRI according to the imaging facility's instructions.