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Important Safety Information

Important Safety Information

Stellaris Elite® and Accessories Important Safety Information

Indications:

The Bausch + Lomb Stellaris Elite® vision enhancement system is intended for the emulsification and removal of cataracts, anterior and posterior segment vitrectomy. The system is designed for use in both anterior and posterior segment surgeries. It provides capabilities for phacoemulsification, coaxial and bimanual irrigation/aspiration, bipolar coagulation, vitrectomy, viscous fluid injection/removal and air/fluid exchange operations. The Stellaris Elite® Vision Enhancement System configured with the laser module is additionally intended for retinal photocoagulation and laser trabeculoplasty.

Contraindications:

  • All Systems: Use of accessories not designated by Bausch + Lomb for use with this equipment may result in serious permanent patient injury, adverse surgical outcome, or damage to the equipment.
  • Systems with Laser Module: Photocoagulation is not indicated for patients without pigmentation (albino eyes). In addition, Laser Indirect Ophthalmoscope (LIO) is not indicated for cases involving laser photocoagulation within the arcades.

Warnings:

  • All Systems:
    • Implantable defibrillators present a risk of injury if triggered by a fibrillatory event during intraocular surgery.
    • Electromagnetic interaction between the phacoemulsification (phaco) handpiece and an implanted cardiac pacemaker is unlikely but cannot be ruled out.
  • Systems with Laser Module:
    • All support personnel who are present during laser treatment must wear appropriate laser protective eyewear.
    • DO NOT look directly into the aiming or treatment laser beam.
    • Use of unapproved delivery devices may cause inaccurate laser delivery which could result in serious permanent patient injury.
  • When using the VITESSE® handpiece:
    • Use only the Entry Site Alignment (ESA) devices provided with the VITESSE® Handpiece Pack (yellow trocar caps). Do not use any ESA with metal components to avoid particulate in the eye.
  • When using the FREEFLOW™ infusion line:
    • Do not attempt to administer intraocular gases or viscous fluids using this device.
    • The infusion line loop should be created in the horizontal plane.

General Cautions for Single Use Accessories:

  • Do not re-sterilize or reuse any single use accessories.
  • Do not use if package integrity / sterile barrier has been breached or compromised.
  • Do not use or attempt to repair damaged single use products.

This is not all you need to know. Systems with Laser Module: Misuse of the laser system may lead to dangerous situations and severe injuries. All Systems: See the appropriate Operator Manual for detailed directions, proper use, and full risk and safety information. See individual product instructions for use for detailed information on the use of the VITESSE® Handpiece, vitrectomy packs and cutters, and the FREEFLOW™ infusion line.

CAUTION: Federal (U.S.) Law restricts this device to sale, by or on the order of a physician.


VITESSE® Handpiece Packs Important Safety Information

Indications:

The Bausch + Lomb VITESSE® handpiece packs are intended for use with a Stellaris Elite® vision enhancement system to remove vitreous humor, lens tissue and other material from the posterior segment of the eye using ultrasound energy and aspiration during a typical or atypical surgery.

Warnings:

  • Do not excessively flex the needle during use
  • Exercise great care when operating near the retina or other sensitive structures within the eye.
  • Bending the needle can lead to needle damage and/or handpiece performance degradation.
  • Use only the Entry Site Alignment (ESA) devices provided with the VITESSE® handpiece pack (yellow trocar caps), do not use any ESA with metal components to avoid particulate in the eye.
  • Only use this product with Bausch + Lomb products and Stellaris Elite® vision enhancement systems. Use of this product with non-Bausch + Lomb products may affect system performance and create hazards.
  • Do not use any item in this pack if received in an unsatisfactory manner.

Cautions:

  • To avoid damage to handpiece internal components, do not submerge the front end of the handpiece body during priming and tuning.
  • Do not allow needle to contact any hard surfaces during priming and tuning.

Medical Device Re-Use Statement

If this product is reprocessed and/or reused, Bausch + Lomb cannot guarantee the functionality, material structure, or cleanliness or sterility of the product.

This is not all you need to know. See the VITESSE® Handpiece Packs instructions for use for detailed directions, proper use, and full risk and safety information.

CAUTION: Federal (U.S.) Law restricts this device to sale, by or on the order of a physician.


FREEFLOW™ Infusion Line Important Safety Information

Indications:

FREEFLOW™ Infusion Line is indicated for the controlled delivery of infusion fluid during vitreoretinal surgery.

Warnings:

  • Known complications include ocular hypertension, hypotony, and choroidal effusion.
  • Do not use the product if the sterile barrier is breached, compromised, wet, or otherwise damaged.
  • Do not attempt to administer intraocular gases or viscous fluids using this device.
  • The infusion line loop should be created in the horizontal plane.

Medical Device Re-Use Statement

  • Do not re-use and/or re-sterilize this product.
  • Do not use or attempt to repair damaged product.

This is not all you need to know. See the FREEFLOW™ Infusion Line instructions for use for detailed directions, proper use, and full risk and safety information.

CAUTION: Federal (U.S.) Law restricts this device to sale, by or on the order of a physician.


Bi-Blade® Vitrectomy Cutter Important Safety Information

Indications:

The Bi-Blade® Vitrectomy Cutter is a pneumatically actuated device that supports aspiration and guillotine-style cutting functions to remove vitreous and/or other tissues from the eye during surgery. The Bi-Blade® Vitrectomy Cutter and the Bi-Blade® Vitrectomy Cutter Packs are intended for use in conjunction with the Stellaris Elite® or Stellaris PC® Vision Enhancement Systems, as specified.

The Bi-Blade® Posterior Vitrectomy Cutter Packs are intended for use for vitrectomy during posterior segment surgery. The Combined Bi-Blade® Vitrectomy Cutter Packs are intended for use for both vitrectomy during posterior segment surgery and for phacoemulsification of an opacified crystalline lens during anterior segment surgery.

Warnings:

  • Failure to follow priming instructions for the vitrectomy cutter and aspiration tubing may result in poor aspiration response and reduction in vitrectomy cutter’s effectiveness.
  • This product should only be used under the guidance of a trained and registered physician.
  • Do not re-sterilize and do not re-use.
  • Only use the Bi-Blade® Vitrectomy Cutter and Bi-Blade® Vitrectomy Cutter Packs with the Stellaris Elite® or Stellaris PC® Vision Enhancement Systems, as specified. Use with non-Bausch + Lomb products may affect system performance and create hazards.
  • Do not use the Bi-Blade® Vitrectomy Cutter or any item in a Bi-Blade® Vitrectomy Cutter Pack if received in an unsatisfactory manner.

This is not all you need to know. See the Bi-Blade® instructions for use for detailed directions, proper use, and full risk and safety information.

CAUTION: Federal (U.S.) Law restricts these devices to sale, by or on the order of a physician.


ADATO® SIL-OIL 5000 Important Safety Information

Indications:

ADATO® SIL-OL 5000 is indicated for use as a prolonged retinal tamponade in selected cases of complicated retinal detachments where other interventions are not appropriate for patient management. Complicated retinal detachments or recurrent retinal detachments occur most commonly in eyes with proliferative vitreoretinopathy (PVR), proliferative diabetic retinopathy (PDR), cytomegalovirus (CMV) retinitis, giant tears, and following perforating injuries. ADATO® SIL-OL 5000 is also indicated for primary use in detachments due to Acquired Immune Deficiency Syndrome (AIDS) related CMV retinitis and other viral infections.

Contraindications:

As silicone oil can chemically interact and opacify silicone elastomers, the use of ADATO® SIL-OL 5000 is contraindicated in pseudophakic patients with silicone intraocular lenses (IOLs).

Warnings:

Oil-induced pupillary block and angle closure can occur in aphakic eyes if a six o’clock iridectomy is not performed. In rare instances, silicone oil could migrate out of the eye and form lesions in the conjunctiva or eyelid. The use of CO2 laser should be avoided in the presence of such silicone oil related skin lesions, due to potential ignition.

Precautions:

  • ADATO® SIL-OL 5000 is supplied in a sterile syringe intended for single use only and contains no preservative.
  • Do not mix oil with any other substances prior to injection.
  • An underfill may result in an ineffective inferior tamponade and an overfill may result in corneal abnormalities and elevated IOP.
  • The use of ADATO® SIL-OL 5000 as a long-term tamponade has not been studied and must be determined by the treating physician. ADATO® SIL-OL 5000 should be removed when, in the judgement of the physician, the retinal attachment would not be compromised.

Adverse Events

Adverse events occurring in the highest percentage of patients include cataract, anterior chamber oil migration, keratopathy, and glaucoma. Other less commonly occurring adverse events in greater than 2% of patients include redetachment, optic nerve atrophy, rubeosis iridis, temporary IOP increase, macular pucker, vitreous hemorrhage, phthisis, traction detachment, and angle block. Complications occurring at rates of less than 2% include subretinal strands, retinal rupture, endophthalmitis, subretinal silicone oil, choroidal detachment, aniridia, PVR reproliferation, cystoid macular edema, and enucleation.

Please see ADATO® SIL-OL 5000 package insert for full prescribing and usage information.

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