SILIKON™ 1000 Oil
Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician.
Indication: SILIKON® 1000 oil 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. SILIKON® 1000 oil is also indicated for primary use in detachments due to Acquired Immune Deficiency Syndrome (AIDS), related CMV retinitis and other viral infections affecting the retina.
- SILIKON® 1000 oil (purified polydimethylsiloxane) is contraindicated in patients with known hypersensitivity to silicone oil.
- SILIKON® 1000 oil is contraindicated in pseudophakic patients with silicone intraocular lenses.
- Oil-induced papillary block and angle closure can occur in aphakic eyes if a six o’clock iridectomy is not performed.
- Do not use a vial for more than one patient.
- Discard unused portion.
- Do not admix with any other substances prior to injection.
- Do not resterilize.
- Do not use expired product.
- An underfill may result in an ineffective inferior tamponade and an overfill may result in corneal abnormalities and elevated IOP.
- The use of SILIKON® 1000 oil as a long term tamponade has not been studied and must be determined by the treating physician. SILIKON® 1000 oil should be removed when, in the judgment of the physician, the retinal attachment would not be compromised.
Attention: Reference the Directions for Use labeling for a complete listing of indications, warnings, precautions, complications and adverse events.