Instructions for Use
INSTRUCTION FOR USE
Core Surgical Ophthalmic Knife
Content
Each blister contains a single sterile ophthalmic knife. The blades are manufactured from medical grade flat stock stainless steel. The handles are manufactured from medical grade co-polymer (polycarbonate). The handles are coloured to differentiate between distinct specifications of eye knife.
Intended Purpose
The intended purpose of Core Surgical’s ophthalmic knife range is to create an incision(s) of a specific size as required during routine ophthalmic surgical procedures.
Indications For Use
Core Surgical’s ophthalmic knife range is used by qualified ophthalmic surgeons during routine ophthalmic surgical procedures to enable subsequent treatment of any patient (no specific demographic) with conditions such as cataract and glaucoma.
The choice of ophthalmic knife for a particular procedure is at the discretion of the qualified ophthalmic surgeon.
Contraindications
No known contraindications
Shelf Life
5 years UKCA Marked
Warnings / Precautions
• The Core Surgical Ophthalmic Knife is designed for single use and must not be re-sterilised to avoid risk of infection.
• Do not use the instrument after expiry date or if the packaging is damaged as device sterility and performance may be compromised.
• Prior to use, inspect the Ophthalmic Knife. Do not use if the blade or handle are damaged.
• The Core Surgical Ophthalmic Knife is only to be used by qualified professionals.
• Used sharps may be contaminated. Disease may occur from injury.
• Used knives should be disposed of in puncture-resistant container.
• The manufacturer shall not be liable for any injury or damage suffered by a patient due to the misuse of the product.
Manufacturer: Core Surgical Limited - Unit B5 Station Yard - Thame - Oxfordshire - OX9 3UH - United Kingdom
Tel: +44 (0)1844 213000 - info@coresurgical.com - www.coresurgical.com - www.eyeknife.com
Please click here for a PDF version of this IFU
A paper hard copy of this IFU is available on request, please contact info@coresurgical.com or call 01844 213000