ADATO SIL-OL 5000 Syringe Silicone Oil



ADATO SIL-OL 5000 is a sterile, highly purified long chain polydimethylsiloxane of the formula (CH3)3SiO-[(CH3)2SiO]n-Si(CH3)3. It is a clear colorless liquid at room temperature with a viscosity of 5000-5900 mPa·s. It has a specific gravity (25°C) between 0.96 and 0.98 g/cm3 and a refractive index (25°C) between 1.403 and 1.405. Each syringe contains solely polydimethylsiloxane oil in neat form.

Key Features & Benefits

  • Pre-filled silicone oil syringe - a convenient way to administer silicone oil
  • Sterile presentation with fewer steps — no filling, spilling, mess or clean-up
  • Single-use, preservative-free disposable syringe

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 resterilize.
  • Discard unused portions of ADATO SIL-OL 5000.
  • Do not mix oil with any other substances prior to injection.
  • Product should be discarded following expiration date.
  • 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.
  • The scleral incisions should be completely sealed to minimize the potential for postoperative extravasation of the oil into the sub-conjunctival space and eyelids.

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.

Adverse Reaction Reporting

Adverse reactions and/or potentially sight threatening complications may be reasonably regarded as ADATO SIL-OL 5000 related and that were not previously expected in nature, severity or degree of incidence should be reported to Bausch & Lomb Incorporated at 1-800-338-2020.

ADATO SIL-OL 5000: Additonal Information



SRG.0026.USA.19