Recipient Vacuum Trephine
Sharp. Accurate. Strong.
The CorneaGen Recipient Vacuum Trephine provides premium accuracy and control along with an ultra-sharp blade that allows for a more vertical cut with reduced undercut. Developed using military sighting technology for outstanding positioning and centration, along with all-metal ergonomic finger grips for maximum control, our recipient vacuum trephine is the definition of sharp, accurate, and strong.
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Details & Specifications
About the Recipient Vacuum Trephine
- Ultra-sharp blade allows for a more vertical cut with reduced undercut
- Industry-leading crosshairs designed using military sighting technology enable outstanding positioning and centration
- All metal ergonomic finger grips provide complete control
Intended Use
The CorneaGen Recipient Vacuum Trephine is designed specifically for performing a full Penetrating Keratoplasty (PK) on the recipient eye, during corneal graft surgery.
Instructions for Use
The instructions for use and suggested surgical technique are supplied in the form of a multi-lingual leaflet with instructions given in diagram form where appropriate. The international symbols used on the packaging are explained in each language. A leaflet is supplied with each product.
Sterilization
Products are sterilized by Ethylene Oxide (EO) according to a validated cycle and the requirements of BS EN ISO 11135- 1:2007, by an approved sterilization sub-contractor, Synergy Health Plc. Doncaster, England. The products have a declared sterile shelf life of five years. Devices are designated for Single Use Only.
Size Options:
All sizes available with or without vacuum.
| Trephine Size (mm) | |||
|---|---|---|---|
| 6.00 | 6.25 | 6.50 | 6.75 |
| 7.00 | 7.25 | 7.50 | 7.75 |
| 8.00 | 8.25 | 8.50 | 8.75 |
| 9.00 | 9.50 | 9.75 | |
Material Specification
| Product Component | Specification |
| Trephine Blade and Cross Hair | Stainless Steel (Blade Depth 1.15mm) |
| Trephine Body and Finger Plates | Aluminum |
| Black Capstan | ABS |
| Tubing | Medical Grade Silicone |
| Syringe | Luer-Lok (5ml capacity) |
| Outer Box/Carton | 500 Micron Printed White Boxboard |
Return Policy
Various circumstances arise that require a customer to return distributed product. For such cases involving any of our products, follow the below returned goods policy.
Products That May Be Returned
Products may be returned in the following cases:
- Damaged during shipment by CorneaGen
- Shipped as a result of CorneaGen error
- Cancelled surgery; when device accompanies CorneaGen processed tissue
- Upon CorneaGen request
Products That May Not Be Returned
CorneaGen will not accept product returns in the following cases:
- Expired products, except in cases where customer lacks destruction capabilities and CorneaGen has pre-authorized the return for destruction
- Post-shipment damaged products, i.e., product damaged while in the customer’s possession
- Products purchased or distributed contrary to law
- Customer’s preference to not use the product
Returned Goods Authorization Process
All returned goods must have prior authorization and be identified with a Return Goods Authorization (RGA) number. The number must be displayed on the shipping carton containing the returned goods and all accompanying paperwork.
A Returned Goods Authorization (RGA) number may be issued only by CorneaGen. Contact us for a RGA number.
- Please call (844) 526-7632 or email products@CorneaGen.com.
When requesting a RGA number, please supply:
- Original Purchase Order number
- Invoice number
- Quantity to be returned
- Reason for the return
Terms of Return Policy
- Returns will be credited at the calculated net purchase price
- Products are subject to a 20% processing charge
- Returned Goods Authorization numbers are only valid for 15 days from date of issue
Transportation and Charges
- Return shipping charges will be prepaid by customer, except in cases where an error due to CorneaGen has occurred
- It is recommended that customers insure all return goods shipments
- All returned products must be in complete and original packaging
- Returned product must be shipped under conditions that maintain its integrity during handling
Reimbursement
If you need assistance with reimbursement of corneal tissue, CorneaGen is pleased to provide its customers with reimbursement and medical claims assistance to help guide you in billing corneal tissue to your local Medicare carrier and other commercial insurance carriers.
Adverse Reaction Reporting
If you have had any complications occur in your recipients, we ask you please file a report with us so that we may comply with EBAA and FDA regulations.
Regulatory Information
CorneaGen’s labs maintain the highest levels of quality through review by the U.S. Food and Drug Administration. For more information, please contact our Quality Assurance and Regulatory Affairs Department at (877) 682-8502.