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Important Safety Information

Viscous Fluid Control

ADATO® SIL-OL 5000 Silicone Oil

Bausch & Lomb’s expanded viscous fluid portfolio includes ADATO® SIL-OL in 5000 mPa·s, the US retina community’s only pre-filled, sterile, and ready-to-use silicone oil syringe.

No More Hand-Pouring

Sterile presentation eliminates the need for filling an injection syringe.

Additional Volume

ADATO® SIL-OL 5000 provides you with an additional 1.5mL of oil compared to vial of leading competitor.

PRE-FILLED, STERILE AND READY-TO-USE SYRINGE

23 AND 25 GAUGE HIGH-FLOW INJECTION CANNULAS

UNIVERSAL COMPATIBLITY

Universal Viscous Fluid Control Pack

The Universal Viscous Fluid Control Pack provides the utility of two packs in a single product, allowing for the efficient injection and extraction of viscous fluids.

Efficient Injections of 5000 mPa·s Oil with High-Flow Cannulas

High-flow injection cannulas are provided in both 23ga and 25ga, eliminating the need to enlarge sclerotomies during small-gauge procedures.

Compatible with Multiple Vitrectomy Platforms

  • Stellaris Elite®
  • Alcon Constellation®
  • Stellaris®PC
  • DORC® EVA

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.