Important Safety Information
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.
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).
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.
- 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 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.