Tarsus Eyelid Patch Product Information
FDA-Listed & Clinically Tested Solution for Eyelid Closure
Patient & Caregiver
Preferred
Clinically Tested
Eye Care
Comfortable & Effective Eyelid Closure Solution
The patented Tarsus Eyelid Patch has undergone meticulous design refinements to ensure both comfort and effectiveness in sustaining eyelid closure for extended periods. Specifically engineered for nighttime wear, it provides essential support for maintaining eyelid closure, making it an ideal solution for addressing conditions such as nocturnal lagophthalmos. Additionally, it offers crucial protection against corneal defects or exposure-related damage, thereby nurturing overall ocular surface health.
Furthermore, our patch serves as a highly effective daytime therapy, securely holding the eyelid in the closed position while preserving moisture and facilitating natural corneal healing. With the flexibility to be worn for up to 12 hours, it seamlessly integrates into daily routines. Depending on the severity of your ocular surface condition, continuous wear may be recommended by your clinician for a week or even a month, with regular changes every morning and night to optimize healing outcomes.
Materials:
Polyolefin plastic, polyester, sticky acrylate designed for medical/surgical use, hypoallergenic soft medical-grade silicone adhesive. DO NOT USE IF ALLERGIC.
Pediatric Eyelid Patch Use
The Tarsus Eyelid Patch is uniquely designed to prioritize comfort, effectiveness, and minimize irritability, making it particularly suitable for pediatric use. In some cases, it can be worn under an eye shield to prevent removal. When addressing conditions such as Lazy Eye, or Amblyopia in young children and adolescents, part-time occlusion of the fellow eye is often recommended to make the weaker eye work harder.
Applied to the upper eyelid above the eye-opening, the Tarsus Eyelid Patch is easily aligned and properly positioned with the assistance of a light blue arching line on the patch itself. Unlike other products that may crush the eyelashes and stick the eyelids together, its design and shape ensure a significantly more comfortable experience. This feature is particularly crucial as irritation caused by traditional products can not only be discomforting but may also result in incomplete eyelid closure, potentially leading to corneal damage, and in severe cases, corneal blindness, especially during sedated surgeries.
Upon application to the closed upper eyelid, the adhesive of the Tarsus Eyelid Patch conforms seamlessly to the curvatures of the eyeball, eyelid, and under brow. This ensures that the patch acquires form and structure, effectively holding the eyelid in the closed position against the retraction of the levator muscle.
Directions for Application & Removal of the Tarsus Eyelid Patch
RECOMMENDED SINGLE USE
Eyelid surface must be clean and dry before applying patch. For use day or night, for up to 12 hours, to sustain eyelid closure.
Remove the eyelid patch from the individual paper packaging.
1
Remove the non-adherent backing from the patch, in the direction of the arrows.
2
Center and apply the patch on the closed upper eyelid, above the eyelashes.
3
Gently rub the patch to ensure it adheres properly to the eyelid.
4
TO REMOVE THE PATCH, gently run your finger over either side edge of the patch, rolling a portion backward. Grip the portion with your fingers and gently remove the patch. Patch removal is painless with no annoying residue.
5
Discard the patch after it has been removed from the eyelid.
6
Warnings:
Skin damage may occur when medical adhesives are not removed gently.
Materials:
Polyolefin plastic, polyester, sticky acrylate designed for medical/surgical use hypoallergenic soft medical-grade silicone adhesive. DO NOT USE IF ALLERGIC.
Medicine Application with the Tarsus Eyelid Patch
Our innovative device and method enable effortless administration of medicine or artificial tears with just one finger. By gently lowering and opening the bottom eyelid, caregivers or wearers can easily apply the necessary medication or liquid tears. Upon releasing the lower eyelid, the upper eyelid is automatically held in the closed position by the Tarsus Patch, ensuring optimal contact and absorption of the medication. This feature not only facilitates the application of eye medicines but also enhances post-surgery healing. Studies have demonstrated that eyelid closure significantly improves the delivery and effectiveness of certain eye medications.
FAQ
Yes, in some cases partial eyelid closure is desired. This can be achieved with the Tarsus Patch by positioning at application. Application positioning is key in all cases. The wearer needs to find the application positioning or sweet spot for their individual orbital eye socket anatomy and the desired amount of eyelid closure desired.
Due to lower lid anatomy or various lower lid functionality issues it may be necessary to support the lower lid to achieve effective eyelid closure.
Yes, FDA CDRH Registration and Listing is…
- FDA Registration Number: 3017733452
- FDA Owner Operator Number: 10079434
- FDA Class 1, 510(K) Exempt.
Classification name: Shield, eye, ophthalmic. Eye patch, non-sterile. Sterile Surgical Adhesive Eye Patch,
Regulation numbers: 878.4440, 886.4750, 81751822161, 81751822147, 81751822123
Specialty code: OP – Ophthalmic
Product code: HOY
Yes.
USPTO Patent numbers: 10076448, and 10,799,395
Patent Attorney: Kregg Koch (currently with Knobbe Martens)
NPPES National Provider Identifier (NPI) #1104411701 for selling Durable Medical Equipment & Medical Supplies. Level II – Classification level code 332B00000X.
Nictavi is a registered U.S. trademark and we have trademark protections in the EU, India and China under the Madrid Protocol through WIPO. https://www.wipo.int/portal/en/
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Temporary Eyelid Closure: These patches can be used to temporarily close the eyelids during certain ocular therapies, medical procedures and settings, such as the ICU, or surgeries where it’s necessary to keep the eye or eyes closed and/or the ocular surface protected.
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Protection of the Ocular Surface: By utilizing eyelid closure, they protect the ocular surface during sleep, especially for those suffering from nocturnal lagophthalmos or eyelid function issues. They are also useful in situations where aided eyelid closure is necessary, or the eyelids need to be closed for extended periods. This helps prevent or address corneal defects and erosion due to exposure.
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Retaining Eye Moisture: In cases of dry eye syndrome or other conditions where the eyes need aided moisture retention, using eyelid closure, these patches help by preventing excessive evaporation of tears, and shielding against exposure.
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Corneal Healing: In cases of corneal abrasions, injuries, and or defects, these patches aid in the healing process by using eyelid closure to create a barrier against exposure and irritation, promoting a moist environment conducive to ocular surface health and healing, effectively making the eyelid a bandage for the eye.
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Therapeutic Applications: They may be used in certain therapeutic procedures where controlled closure of the eyelids is required, such as during ocular amniotic membrane or stem cell therapies, and in the application of certain eye medications where eyelid closure enhances absorption and effectiveness.
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Eye Alignment: In cases of strabismus and amblyopia, these patches can be used to temporarily close one eye, blocking vision in that eye to strengthen the other eye and help improve alignment.
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Cosmetic/Beauty: In some cosmetic or beauty treatments, these patches may be used to temporarily stabilize the eyelids.
Yes, here are a list of our distributors:
- Alpha-net. Based in Israel, and has operations in 32 other countries including South America https://www.alpha-net.co.il/ophtalmology
- Medix21. Based in New Zealand, also distributes in Australia: https://medix21surgical.co.nz/
- Our exclusive distributor to the markets of the European Union is based in Spain. https://tienda.lacuite.com/es/ EU EUDAMED SRN:US-MF-000041330, CE mark, MD.
- Dry Eye Rescue – https://dryeyerescue.com/
- Walmart Online – https://www.walmart.com/ip/Nictavi-Disposable-Device-for-Nighttime-Eye-Lid-Closure-15ct/2568096590
Certifications & Registrations
State of California Small Business Certification ID 2028555 (SB micro)
County Local Small Business Enterprise (LSBE)- 092569
Los Angeles County Community Business Enterprise Program (CBE) as a MBE- 092570
LA RAMP as Nictavi LLC, DBA Nictavi ID 203120
LA County Vendor Number: 206417
Certified by the Southern California Minority Supplier Development Council and the NMSDC, as a Minority Business Enterprise (MBE) and we have been added to NMSDC CENTRAL®, the MBE database. #SC49195#minorityownedbusiness #Nictavi #SCMSDC #NMSDC #certification
Codes
NAICS:
423460 – Ophthalmic Goods Merchant Wholesalers, Ophthalmic Goods (except cameras) Merchant Wholesalers, Optometric Equipment and Supplies Merchant Wholesalers
339115 – Ophthalmic Goods Manufacturing
423450 – Medical, Dental, and Hospital Equipment and Supplies Merchant Wholesalers
SIC:
5048 – Ophthalmic Goods
5995 – Optical Goods Stores
5047 – Medical and Hospital Equipment
CMS assigned HCPCS code: A6412 – Eye patch, occlusive, each.
Recognized by the https://aaopt.org/ in 2022, as one of the top 15 most innovative startups in optometry.
Wholesale Purchasing
Nictavi accepts purchase orders via email and is open to negotiate large volume recurring purchasing.
The minimum quantity of boxes to qualify for a wholesale bulk purchase order is 6 boxes.
