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The ESA is a hand-held surgical instrument intended for use as a trocar/cannula for establishing an entry site conduit for passing ophthalmic instruments/accessories used to perform posterior ophthalmic surgical procedures.

Bausch & Lomb's Entry-Site Alignment system (ESA) is a 25ga disposable cannula system used to access the posterior segment of the eye for various ophthalmic surgical procedures. The ESA system is used to establish and maintain a surgical orifice for infusion as well as insertion and removal of surgical instruments used during posterior ophthalmic surgical procedures. The ESA system will be EtO sterilized with a minimum SAL level of 10°. The ESA system will be provided sterile, single-use in the following configuration: (3) Insertion tool assemblies (needle/cannula) (3) Cannula pluas (1) Infusion line The ESA insertion tool assembly is constructed of polycarbonate handle with a thin wall stainless steel needle affixed to the distal tip of the insertion tool handle. via a medical grade adhesive. The intravenous point of the needle allows for ease of piercing through the conjunctiva and sclera vs. the traditional dissection of the conjunctiva and sclera. The cannulas are constructed of thin-wall stainless steel with an polycarbonate hub and are manually attached to the ESA insertion tool and locked (via a slight twist) into place (provided pre-assembled). The cannula lumen is designed to accommodate passage of various 25ga surgical instruments for posterior surgical procedures. The cannula plugs are constructed of a medical grade ABS polymer and are intended for insertion into the entry-site cannula(s) to seal the cannula port when not in use. The silicone infusion line, connected to a chosen surgical entry site, is intended to infuse through cannula port while performing surgical procedure. During use, the ESA svstem is manually advanced through the conjunctiva and sclera. Once an incision is established, the insertion tool/needle is removed and the cannula remains in place at the chosen surgical entry site(s). Following placement of the trocar(s), a chosen cannula port is utilized as an infusion site for which the infusion tube is attached. The desired posterior segment procedure is performed advancing and removing surgical instruments through the lumen of the positioned cannulas. After the procedure is completed the cannulas are simply removed from the eye using forceps.