Alcon at ASCRS

UNITY^® VCS and CS Important Product Information

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

Indications / Intended Use:

UNITY VCS:

The UNITY VCS console, when used with compatible devices, is indicated for use during anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e. vitreoretinal) ophthalmic surgery.

In addition, with the optional laser this system is indicated for photocoagulation (i.e. vitreoretinal and macular pathologies), iridotomy and trabeculoplasty procedures.

UNITY CS:

The UNITY CS console, when used with compatible devices, is indicated for use during anterior segment (i.e. phacoemulsification and removal of cataracts) ophthalmic surgery.

Warnings:

Appropriate use of UNITY VCS and CS parameters and accessories is important for successful procedures. The console supports various accessories to perform various surgical procedures. Accessories include handpieces and probes, as well as tips and sleeves when necessary. Different accessories are required for different procedures and operating modes.

Test for adequate irrigation and aspiration flow, reflux, and operation of each accessory prior to entering the eye.

The consumables used in conjunction with ALCON^® instrument products constitute a complete surgical system. To avoid the risk of a patient hazard, do not mismatch consumable components or use settings not specifically adjusted for particular consumable component combinations.

AEs / Complications:

Inadvertent activation of functions that are intended for priming or tuning accessories while the accessory is in the eye can create a hazardous situation that could result in patient injury.  During any ultrasonic procedure, metal particles may result from inadvertent touching of the ultrasonic tip with a second instrument. Another potential source of metal particles resulting from any ultrasonic handpiece may be the result of ultrasonic energy causing micro abrasion of the ultrasonic tip.

ATTENTION:

Refer to the Directions for Use for the accessories/consumables and User Manual for a complete listing of indications, warnings, cautions and notes.

Clareon^® PanOptix^® Pro Trifocal IOLs

IMPORTANT PRODUCT INFORMATION

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

INDICATIONS: The Clareon^® PanOptix^® Pro Trifocal IOLs include Clareon^® PanOptix^®  Pro and Clareon^® PanOptix^® ProToric and are indicated for primary implantation in the capsular bag in the posterior chamber of the eye for the visual correction of aphakia in adult patients, with less than 1 diopter of pre-existing corneal astigmatism, in whom a cataractous lens has been removed. The lens mitigates the effects of presbyopia by providing improved intermediate and near visual acuity, while maintaining comparable distance visual acuity with a reduced need for eyeglasses, compared to a monofocal IOL. In addition, the Clareon^® PanOptix^® Pro Toric Trifocal IOL is indicated for the reduction of residual refractive astigmatism.

WARNINGS/PRECAUTIONS: Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting a lens in a patient with any of the conditions described in the Directions for Use labeling. Physicians should target emmetropia, and ensure that IOL centration is achieved.

For the Clareon^® PanOptix^® Pro Toric Trifocal IOLs, the lens should not be implanted if the posterior capsule is ruptured, if the zonules are damaged, or if a primary posterior capsulotomy is planned. Rotation can reduce astigmatic correction; if necessary lens repositioning should occur as early as possible prior to lens encapsulation.

Some visual effects may be expected due to the superposition of focused and unfocused multiple images. These may include some perceptions of halos, radial lines around point sources of light (starbursts) under nighttime conditions, or glare, as well as other visual symptoms. As with other multifocal IOLs, there is a possibility that visual symptoms may be significant enough that the patient will request explant of the multifocal IOL. A reduction in contrast sensitivity as compared to that expected with a monofocal IOL may be experienced by some patients and may be more prevalent in low lighting conditions. Therefore, patients implanted with multifocal IOLs should exercise caution when driving at night or in poor visibility conditions.

Patients should be advised that unexpected outcomes could lead to continued spectacle dependence or the need for secondary surgical intervention (e.g., intraocular lens replacement or repositioning).

As with other multifocal IOLs, patients may need glasses when reading small print or looking at small objects. Posterior capsule opacification (PCO), may significantly affect the vision of patients with multifocal IOLs sooner in its progression than patients with monofocal IOLs. Prior to surgery, physicians should provide prospective patients with a copy of the Patient Information Brochure available from Alcon informing them of possible risks and benefits associated with the IOLs.

ATTENTION: Reference the Directions for Use labeling for each IOL for a complete listing of indications, warnings and precautions.

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.

Important Product Information – WaveLight^® Plus laser systems

CAUTION: Federal law restricts this device to sale by or on the order of a physician.

DESCRIPTION AND CHARACTERISTICS:

The WaveLight^® Plus laser systems is a non-contact ophthalmic diagnostic device designed to capture Scheimpflug images of the anterior segment of the eye, which includes the cornea, pupil, anterior chamber, and lens of the eye. Furthermore, it provides the axial dimensions of the eye using the technology of coherence interferometry. It can also measure the optical aberrations of the eye by applying Hartman-Shack wavefront technology.

INDICATION:

The WaveLight^® Plus laser systems is indicated for screening and diagnosis of adult patients who may undergo a customized photorefractive treatment with the WaveLight^® Plus laser systems.

The WaveLight EX500 laser system in conjunction with WaveLight^® Plus Sightmap is indicated for use in INNOVEYES Laser Assisted In-Situ Keratomileusis (“wavelight plus”1 LASIK) treatments:

for the reduction or elimination of myopia or myopia with astigmatism, in eyes with spherical equivalent (SE) more than -1.00 and up to - 9.00 diopters (D), with up to - 8.00 D of spherical component (in minus cylinder format) and up to - 3.00 D of astigmatic component at the spectacle plane, based on the INNOVEYES Sightmap Measured Refraction

in patients with magnitude of the spherical equivalent (SE) difference between the Manifest Refraction (MRSE) and the Sightmap measured refraction SE being less than 0.75 D,

in patients who are 18 years of age or older, and

for patients with documentation of a stable manifest refraction defined as ≤ 0.5 D preoperative spherical equivalent shift over one year prior to surge.

CONTRAINDICATIONS:

If you have any of the following situations or conditions, it is not recommended to have an examination with the WaveLight^® Plus laser systems.

Patients with open wounds and sores getting in contact with the head rest must not be examined.

There are no other known contraindications to the use of the WaveLight^® Plus laser systems when used according to its approved indications.

TARGET PATIENT POPULATION:

The targeted patient population are patients which are selected for ophthalmic diagnosis consistent with the indications for use of the WaveLight^® Plus laser systems.

INTENDED USERS:

The WaveLight^® Plus laser systems may only be used by specially trained physicians, medical staff and optometrists who are well versed in its diagnostic abilities and possible dangers.

WARNINGS / PRECAUTIONS:

Contact lens wearers must discontinue wearing hard or gas permeable lenses for at least 3 weeks and soft lenses for at least 1 week prior to examination.

The examination takes place in a darkened room or with the help of a dark cloth covering the WaveLight^® Plus laser systems and the patient’s head.

The patient must be able to sit in an upright and comfortable position.

The patient must be able to fixate steadily.

Patients should not wear makeup at the day of examination.

Avoid using eye-drops before examination. It may impact the diagnostic results and should be reported to the surgeon.

Taking medication with influence on the hormonal balance can affect the consistency of the cornea.

Results may be influenced by pregnancy and nursing. Hormonal changes can affect the consistency of the cornea.

This device can cause flammable materials to ignite or explode.

Use of the controls or adjustments or performance procedures other than those specified in the user manual may result in hazardous radiation exposure.

MODE OF ACTION:

The mode of action of the WaveLight^® Plus laser systems is through the screening and diagnosis of anterior segment of the eye for planning custom refractive surgery treatments with the intent of improving vision.

STORAGE CONDITIONS:

Store at -10-55°C (14-131°F).

ATTENTION: Refer to the Directions for Use labeling for a complete list of warnings, precautions, and adverse reactions.