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Bausch Health Gains PMA for Cataract Surgery Ophthalmic Device
The FDA has granted premarket approval (PMA) to Bausch Health Companies’ StableVisc ophthalmic viscosurgical device which prevents tissue damage during cataract surgery.
StableVisc is a sterile solution of highly purified, medium molecular weight sodium hyaluronate which maintains the eye’s anterior chamber space, re-inflates the capsular bag for intraocular lens insertion and protects the cornea from surgical instruments and ultrasonic energy.
The product’s viscosity offers structural stability in the eye and creates space in the chamber during surgery.
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