Alcon Voyager™ DSLT Important Product Information

Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician.

Intended Use: Voyager™ DSLT is a prescription device intended for use in performing selective laser trabeculoplasty.

Indications: Voyager™ DSLT is indicated for use in selective laser trabeculoplasty (SLT).

Contraindications:

• Use of the Voyager™ DSLT device is contraindicated in the following patients: Patients who are unable to fixate their head and/or eyes, such as patients suffering from uncontrolled nystagmus, tremors or similar conditions.
• Patients with a pupil that cannot constrict to a diameter of 4 mm or less.

Warnings:

• Users should wear laser safety eyewear while performing a procedure with the Voyager DSLT device to avoid injury to the user's eyes.
• Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous laser radiation exposure.
• Caution should be used when treating patients who have active uveitis or neovascularization that involves the iridocorneal angle with the Voyager DSLT device.
• The effect of selective laser trabeculoplasty energy on glaucoma implants located in the iridocorneal angle has not been studied. Because your version of the Voyager DSLT device does not allow masking of the implant area (i.e. ability to program a laser pattern which skips the local area of the implant), the use of the device is not recommended in eyes which have a glaucoma implant at any clock hour in the iridocorneal angle.
• In the pivotal clinical study of the Voyager DSLT device, the safety and effectiveness of re-treatment was not studied; therefore, the level of IOP reduction and potential for complications associated with re-treatment has not been established. Re-treatment is not recommended.

ATTENTION: Refer to the Voyager™ DSLT Directions for Use operating instructions and for the accessories/consumables and User Guide for a complete listing of indications, warnings, cautions and notes.