Johnson and Johnson Vision
United States
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Important Safety
Summary of Important Safety Information:

Indication: The IntraLase FS & iFS lasers are surgical lasers that can be used to create flaps for use in laser-assisted in situ keratomileusis (LASIK) surgery.

Contraindications: You should not have LASIK flaps made using the IntraLase FS or iFS lasers if you have certain preexisting eye conditions. Tell your doctor about any eye-related conditions, injuries, or surgeries you have had.

Adverse events: Possible complications resulting from LASIK flap creation include swelling, inflammation or pain in your eye, infection, or flap-related complications. Mild to severe light sensitivity occurred in 1% of patients between 2 and 6 weeks after surgery. Some patients (0.03%) noticed a temporary spoke-like band of light in their peripheral vision.

Caution: U.S. Federal law restricts these devices to practitioners who have been trained in their calibration and operation, and who have experience in the surgical treatment and management of refractive errors.

Patients are requested to consult with their eye care professional for a complete listing of the contraindications and risks. U.S. Federal Law restricts this device to sale, distribution, and use by or on the order of a physician or other licensed eye care professional.

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