What is Tear Duct Occluder TM ?
Tear Duct OccluderTM (also known as Eyedrops Occluder) is an FDA approved only noninvasive Nasolacrimal Occlusion (NLO) device which has to be sold or prescribed by a licensed eye care professional. This device is intended to temporarily occlude the nasolacrimal ducts in adult patients to help reduce outflow through the nasolacrimal ducts. The device is made of highly corrosion-resistant stainless steel and the skim contact portions are covered with soft silicon rubber to enhance wearing comfort and prevent skim irritation. FDA has reviewed and approved that Tear Duct OccluderTM can perform Tear Duct Occlusion effectively and safely on April 20, 2016 and currently it is the only noninvasive nasolacrimal occlusion device FDA has ever approved.
FDA Classification – 21 CFR 886.5838
On April 20, 2016, under our De Novo Request DEN140022, FDA established a new ophthalmic device classification, 21 CFR 886.5838, for Tear Duct OccluderTM and classified it into class I under the generic name, Nasolacrimal Compression Device.
FDA identified this generic type of device as:
“A prescription nasolacrimal compression device that is fitted to apply mechanical pressure to the nasal aspect of the orbital rim to reduce outflow through the nasolacrimal ducts.”
Tear Duct OccluderTM is the brand name of the generic device “Nasolacrimal Compression Device ”
FDA’s definition a noninvasive nasolacrimal compression device can be summarized as follow:
A nasolacrimal compression device is a device used to compress the nasolacrimal ducts at nasal aspect of orbital rim to reduce drainage by means of temporary occlusion of the nasolacrimal system. The device may include a nose piece attached to a frame to apply pressure to the ducts.
The device frame material is durable and flexible enough to appropriately fit the patient and maintain nose pad placement. The nose pads from which the pressure is applied include padding to mitigate risk of abrasion. The device uses a nose piece to apply direct pressure to the top of the nasal aspect of the orbital rim to occlude the ducts during application of the pressure. The pressure is controlled by means of tightening a Velcro strap that is worn around a patient’s head. The device has a failure mechanism to protect against applying excessive pressure.
Safety & Effectiveness
Tear Duct OccluderTM is indicated to temporarily occlude the nasolacrimal ducts in adult patients to reduce outflow through the nasolacrimal ducts. Federal law restricts this device to sale by or on the order of a licensed eye care professional. This device has not been evaluated for pediatric use. This device must be fitted by a lecensed eye care professionl before use. Wear this device for 5 minutes at a time. Patients should consult the licensed eye care professional with regard to the use of this device, in case of open globe, post-surgery, infection, and inflammation. Patients are advised to stop using this device should the skin, in contact with the device, develop irritation. This device should not be used if patients use anti-coagulants.
This device is to be replaced every 6 months. Over-use may lead to device fracture and/or compromising Velcro fastening ability. The device should fit the nasal aspect of patient’s orbital rim seamlessly. Improper fit of the device will render the device non-functional. See Tear Duct OccluderTM User Instruction and troubleshooting guide for details.
For more detailed safety and effective information, please see Tear Duct Occluder Labeling.