Structural device failure, as mode of injury or harm

**Definition:** Harm arising due to mechanical or material device failure not related to the installation of the device.

**Inclusions:** - Leakage from device, as mode of injury or harm - Wear, breakage or breakdown of device, as mode of injury or harm - Breakdown of intraocular lens

**Exclusions:** - Wear of articular bearing surface of joint prosthesis - Combination or interaction of operator error and device failure, as mode of injury or harm - Structural device failure without injury or harm