MAKEDGE
Ophthalmic Micro Surgical Knives
Consistent Performance :
MAKEDGE ophthalmic surgical instruments are engineered for consistent performance, enhancing reliability and safety across surgical procedures. Manufactured with an advanced automated process known as electro-etching, each blade is precisely formed for high sharpness and uniform quality. Every instrument is produced through controlled processes that uphold strict quality standards, delivering dependable performance for healthcare professionals and safe use in surgical environments.
Precise and Sharper Blade :
MAKEDGE instruments are crafted using advanced electro-etching and electro-polishing processes to produce sharp, high-precision blades. This manufacturing approach supports reliable blade quality that aligns with the demands of modern ophthalmic surgery. The precision blades help surgeons perform fine ophthalmic procedures with control and accuracy, contributing to consistency in surgical performance.
Anti-Glare :
MAKEDGE instruments feature a matte finish designed to reduce glare from operating room lighting. This helps improve visibility of the blade within the eye chamber and supports a clearer view of the surgical field, aiding focus during intricate ophthalmic procedures.
IFU FOR OPHTHALMIC KNIVES
Intended use
Ophthalmic Microsurgical Knives are used to make precise incisions for ophthalmic surgery the precise incisions achievable with these knives are among the preconditions for application in delicate ophthalmic surgical interventions.
Further information
1. Construction
 | a. Handling of the caseI) Taking out the knife: with special care to keep the blade off any other part of the case, pick up device and raise the knife. Note that the knife may lose its sharpness once its blade touches an object. II) Replacing the knife: Holding the knife with its blade edge facing downward, fully press at position locking then lightly press Handle until you hear a click. |
Material
Blade: Stainless steel
Handle:Polycarbonate
Tray: Polycarbonate
- Each ophthalmic knife is individually packed sealed in a pouch to ensure These products are sold in boxes.
- The device is intended to be used by trained ophthalmic surgeon
Instruction for use
Select the appropriate type of knife for each surgical purpose. Use in accordance with the usual surgical procedures.
Warnings/Precautions for safe handling
- Read, follow and keep the instruction for
- Use the product only in accordance with its intended use, see intended
- Store any new products in a dry, clean and safe
- Avoid high temperature, high humidity, direct sunlight, soaking and preserve at room temperature
- Do not preserve at the chemical products place and gas occurrence place
- Preserve at the status of non-break to package material and non-pinhole
- It is necessary to confirm the use period on each package and box
- By confirming the use period on each package and box, dispose the products which expire the use period.
- Prior to each use, inspect the product for: loose, bent, broken, cracked, worn or fractured
- Do not use the product if it is damaged or Set aside the product if it is damaged.
- Avoid contact of the delicate blades at tips with hard surfaces or other instruments.
- Dispose of the used knife in a medical waste basket and follow the instructions
- Use the knife as soon as it is unpacked. Dispose of the used knife with care to prevent
IFU FOR OPHTHALMIC KNIVES
Contraindication-Prohibition
- Re-use prohibited
The device is supplied sterile and is supposed to be disposed of, as per hospital policy, after each use. However, if the doctor or hospital reuses the device, it can cause severe infections apart from other complications.
- Re-sterile prohibited
A device with broken sterile barrier may be non-sterile and it should not be re-sterilized. This may cause infection and other complications to the patient, if still used by the doctor/ hospital.
- Do not use after expiry date
- Do not use if it is considered that the products aseptic condition is spoiled by broken
Symbols and Explanations
| Sl. No. | Symbol | Title of the symbol |
| 1 |  | European Conformity mark |
| 2 |  | Manufacturer |
| 3 |  | Authorized Representative in the European Community |
| 4 |  | Date of manufacture |
| 5 |  | Use-by date |
| 6 |  | Sterilized using Ethylene Oxide |
| 7 | Do not reuse | |
| 8 |  | Do not re-sterilize |
| 9 |  | Batch code |
| 10 |  | Keep away from sunlight |
| 11 |  | Keep dry |
| 12 |  | Caution |
| 13 |  | Do not use if package is damaged and consult instructions for use |
| 14 |  | Medical Device |
SHIPPING POLICY
We strive to provide a seamless shipping experience for our customers. Here’s what you need to know:
Processing Time: Orders are generally processed and prepared for shipment within 1-2 business days after payment confirmation.
Shipping Methods: We offer various shipping options, including standard and expedited delivery services to meet your needs.
Shipping Rates: Shipping costs are calculated based on the destination and weight of the order. You can view the shipping fees during checkout before completing your purchase.
Delivery Time: Delivery times vary depending on your location and the selected shipping method. Estimated delivery times will be provided at checkout.
Tracking Information: After your order is shipped, you will receive a confirmation email with tracking details so you can monitor its progress.
RETURN POLICY
We want you to be fully satisfied with your purchase. Here are the details of our return policy:
Full Credit: A full credit will be issued for any MAKVIN Surgical instrument returned within 90 days of the invoice date.
Non-Returnable Products: The following items are not eligible for return:
– Any sterile product that has been opened
– Any product returned outside of its original packaging
– Any distributed product returned with damage to the box or label
– Any custom etched instrument
– Any custom made instrument
Return Process: To return any product(s) to Makvin Surgical, you must first obtain a Returned Goods Authorization (RGA) number. This number can be issued by contacting our customer service team at 1-800-xxx-xxxx. Please note that obtaining an RGA number does not guarantee final credit to your account. Makvin Surgical reserves the right to review and evaluate all returned items before issuing any credit.
For a return to be processed, all products must be sent back in their original condition. This includes returning the item(s) with all original packaging, boxes, bags, labels, and Instructions for Use (IFU).
If a product is deemed non-returnable, it will be sent back to the customer at our expense, along with a letter explaining the reason for its non-returnability.
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