ASF Ophthalmic Eye Shield

The ASF Ophthalmic Eye Shield, sized Medium, is designed for essential eye protection and post-surgical care within hospital environments. This shield serves to protect the eye and securely hold dressings in place after surgical procedures, as well as to safeguard an injured eye from further damage.

Constructed from durable polycarbonate plastic, the eye shield features ventilation holes that facilitate airflow to prevent moisture buildup. Its design contours to fit comfortably over the eye socket without making contact with the eye, ensuring that the edges rest on the surrounding bones for patient comfort and protection. The shield can be secured using surgical tape, elastic straps, or by fitting it into eyewear. Depending on the material and proper cleaning protocols, this eye shield is suitable for either reusable or disposable applications.

Ophthalmic eye shields made of plastic are classified by the FDA as Class I medical devices, falling under general controls. This classification exempts them from premarket notification procedures and current good manufacturing practice requirements when made solely of plastic or aluminum. For reusable shields, recommended sterilization methods include autoclaving, ETO gas sterilization, and STERRAD gas plasma, ensuring compatibility with standard hospital reprocessing protocols.

Key Features : 

Provides protection for the eye and secures dressings post-surgery, and shields injured eyes from further trauma.
Features a polycarbonate plastic construction with ventilation holes to prevent moisture accumulation.
Designed to contour over the eye socket without direct contact, ensuring comfortable and secure placement.
Supports reusability with compatibility for sterilization via autoclave, ETO gas, or STERRAD gas plasma, or can be disposed of after single use.
Classified as an FDA Class I medical device under general controls.