Surgical
ADATO SIL-ol 5000 - Brief Statement
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
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.
Precautions
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.
