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IMPORTANT SAFETY INFORMATION

Indications for Use

The IntraLase® FS and iFS® Lasers are 21 CFR 1040 class IIIb ophthalmic surgical lasers with the following indications for use:

The IntraLase® FS and iFS® Laser delivery systems are used in conjunction with a sterile disposable IntraLase Patient Interface, consisting of pre-sterilized suction ring assemblies and pre-sterilized applanation lenses, intended for single-use.

The ® FS and iFS® Lasers should only be operated by, or under the direct supervision of a trained physician with certification in laser safety and in the use of the IntraLase® FS Laser.

Flap Contraindications

Lamellar resection for the creation of a corneal flap using the IntraLase® FS or iFS® Lasers is contraindicated if any of the following conditions exist. Potential contraindications are not limited to those included in this list:

IntraLase Enabled Keratoplasty (IEK) Contraindications

Contraindications to use of the IntraLase® FS or iFS® Lasers for the indications described for the IEK procedure include:

The following conditions should also be considered when using the IntraLase® FS or iFS® Lasers for IEK:

Warnings

FS and iFS® Lasers

Patient Interface

Flap Complications

Possible complications resulting from Lasik surgery include (potential complications are not limited to those included in this list):

The following sporadically reported visual symptoms may occur following LASIK flap creation with the IntraLase® FS or iFS® Laser.

Transient Light Sensitivity Syndrome (TLSS)

Transient Light Sensitivity Syndrome is characterized by symptoms of mild to severe light sensitivity which manifests between two and six weeks postoperatively. Patients experience no decrease in uncorrected or best spectacle-corrected visual acuity. The incidence of this sensitivity is observed in approximately 1% of patients who undergo flap creation with the IntraLase® FS laser. Patients respond to the use of hourly topical steroids such as Pred Forte, and most report improvement within one week of treatment.

Peripheral Light Spectrum (PLS)

Peripheral Light Spectrum (PLS) is a temporary phenomenon whereby patients report the perception of a spoke-like spectrum of light in the periphery of their vision. PLS has no clinical examination findings and no effect on visual acuity; however the potential diffractive effects may be bothersome to some patients. Reported in only 0.03% of cases, the onset of symptoms occurs during the immediate postoperative period, and typically resolves within three months but may be slightly persistent in rare cases. The visual impact of PLS is clinically inconsequential for the vast majority of patients.

US Federal law restricts this device to sale, distribution, and use by or on the order of a physician or other licensed eye care practitioner.

The product may contain mercury. Please dispose accordingly to state, local or federal laws.