Important Safety Information
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.
Please see DFU for a complete list of instructions, contraindications, warnings, and precautions.