iAccess^® Important Safety Information

Indication For Use

The Glaukos iAccess^® Trabecular Trephine is intended for use in ophthalmic surgical procedures to manually cut trabecular meshwork ^TM in pediatric and adult patients.

Contraindications

The Glaukos iAccess^® Trabecular Trephine is contraindicated in eyes where there is poor visualization of angle structures.

Warnings / Precautions

Physician training is required prior to use of the iAccess^® Trabecular Trephine, including intraoperative gonioscopy. Do not use the Glaukos iAccess^® Trabecular Trephine if there is poor visualization of angle structures. Improper visualization could result in damage to adjacent eye structures. Do not re-sterilize or reuse the device as this may result in infection and/or intraocular inflammation, as well as occurrence of potential postoperative adverse events.

Caution

Federal law restricts this device to sale by, or on the order of, a physician.