Quick facts
- A tear duct occluder is a named Class I device in the United States at 21 CFR 886.5838.
- Canada names no tear duct occluder. A device placed in the tear drainage pathway is an invasive device, and Rule 2(1) of the Medical Devices Regulations places it in Class II.
- A device intended to remain in the body for 30 consecutive days or more moves to Class III under Rule 2(3).
- The same plug is therefore Class I in the United States and Class II or III in Canada, set by how long it is meant to stay in place.
- A punctal plug sits at the opening of the tear drainage pathway; it does not reach the eye surface, but it does enter the body through a body orifice.
- The regulation text quoted here is current to 2026-09-21 and was last amended on 2026-06-17.
A tear duct occluder, often called a punctal plug, is a small device placed at the opening of the tear drainage pathway to hold tear on the eye. It is used when a dry eye loses tear down the drainage path faster than the surface can use it. The device is tiny, and the two countries place it in different classes because they ask how long it stays in the body.
What is a tear duct occluder?
The tear film drains from the eye through a small opening at the inner corner of each lid, called the punctum, into a canal that leads to the nose. A tear duct occluder is a plug placed at or just inside that opening to slow the drainage. Some plugs are placed on the lid margin and sit at the punctum; others are pushed into the canal.
The plug is a physical block. It does not emit anything and it does not contain a drug unless it is a drug-eluting version, which is a separate product with a separate route. The feature that decides its class is the fact that it enters the tear drainage pathway through the body's own opening, and the length of time it is meant to stay there.
How do Canada and the United States classify a tear duct occluder?
The plug is Class I on one side of the border and Class II or III on the other, because the two rulebooks read duration differently.
| Item | Canada | United States |
|---|---|---|
| Tear duct occluder | Class II by Rule 2(1) | Class I, 21 CFR 886.5838 |
| Basis named in the rulebook | Rule and intended use | Device entry and product code (PLX) |
| What decides the class | That it enters the body and how long it stays | Which named entry it is filed under |
| Plug left in place 30 days or more | Class III by Rule 2(3) | Still the same named entry |
| Drug-eluting plug | Separate route, separate evidence | Separate entry and drug review |
In the United States the plug is a named entry at 21 CFR 886.5838, and a product filed under that entry is Class I. In Canada no entry names the plug. The Regulations define an invasive device as one that enters the body through a body orifice or the body surface, or that contacts the surface of the eye, and Rule 2(1) classifies every invasive device that penetrates the body through a body orifice as Class II. The punctum is a natural opening, so the plug is invasive and the base class is II.
The step that a supplier has to watch is Rule 2(3). A device that is normally intended to remain in the body for at least 30 consecutive days is classified as Class III. A plug designed for long-term retention crosses that line; a plug that is placed and removed within the visit, or that dissolves, does not.
Which documentation differs between Canada and the United States?
The class is where the paperwork starts, and the two pathways do not start in the same place.
In the United States a Class I device that is not exempt is placed on the market through the premarket notification route, and the manufacturer keeps the records that entry requires. In Canada a Class II device needs a medical device licence, supported by a quality-system certificate against ISO 13485 and by the labelling and evidence the Regulations set out; a Class III device carries a heavier application again, with a review of the clinical evidence for the device. A supplier that ships a long-wear plug into Canada believing it is a US-style Class I accessory is holding a Class III device with the wrong file.
The practical consequence is concrete. The material of the plug is unchanged between markets. What changes is that the duration the plug is designed to stay in place selects the Canadian class, and the class selects the depth of the application.
Why does the plug move class with time in Canada?
Because the Canadian rulebook grades an invasive device by how long it is meant to stay inside the body.
Rule 2(1) sets the base class at II for any invasive device that penetrates a body orifice or touches the surface of the eye. Rule 2(2) steps a device down to Class I only when it is placed in the oral or nasal cavity as far as the pharynx, or in the ear canal up to the ear drum — the tear drainage pathway is neither. Rule 2(3) steps a device up to Class III when it is normally intended to remain in the body for at least 30 consecutive days. Rule 2(4) covers a device presented as preventing the transmission of infectious agents during sexual activity, which is not this product.
A punctal plug sits in the first band and, if it is a long-term plug, the third. The design rule is simple to state: read the entry route, then read the intended duration, then read the exceptions. A plug that touches the surface of the eye rather than the drainage opening would instead meet the contact limb of Rule 2(1).
Which consumables does a dry-eye procedure room restock?
A room that fits and reviews plugs runs on the same bench supplies as any other lane. The smooth white exam table paper covers the headrest between patients, and the double-tipped cotton swabs handle the lid margin preparation that comes before the plug is placed. Where a sample is taken at the bench, the sterile graduated 90 mL specimen cups carry it away, and a clinic that runs its own steriliser pairs the sterilization monitoring collection with the 24-hour monitoring five-pack trial. Clinics and multi-site groups ordering at case level use the wholesale ordering page, and the B2B wholesale collection lists the lines held for institutional buyers. Reselling? become a distributor.
What do the two rulebooks actually say?
The two texts are short, and reading them side by side shows where the duration line is drawn.
| Rule or entry | Verbatim wording | Effect on a tear duct occluder |
|---|---|---|
| Rule 2(1), Canada | penetrate the body through a body orifice or that come into contact with the surface of the eye | The plug enters through the punctum, so Class II |
| Rule 2(2), Canada | placed in the oral or nasal cavities as far as the pharynx or in the ear canal up to the ear drum | Does not apply to the tear pathway |
| Rule 2(3), Canada | remain in the body or in contact with the surface of the eye for at least 30 consecutive days | Moves a long-wear plug to Class III |
| 21 CFR 886.5838, US | Tear duct occluder | Named Class I entry |
| Rule 7(1), Canada | all other non-invasive devices are classified as Class I | Does not apply, because the plug is invasive |
Read together, the lines give a supplier a single question to answer before a market entry: how long is this plug designed to stay in place. That answer, not the material or the size, decides whether the Canadian file is a Class II or a Class III application.
Sources
- 21 CFR 886.5838, tear duct occluder
- 21 CFR 886.1800, Schirmer strip
- 21 CFR 886.3130, ophthalmic conformer
- 21 CFR 886.1040, ocular esthesiometer
- 21 CFR 886.5925, soft contact lens
- Medical Devices Regulations, SOR/98-282, full text
- openFDA device classification API
- ISO 15004-1:2020, ophthalmic instruments, general requirements
- ISO 13485:2016, medical devices quality management
- ISO 14971:2019, risk management for medical devices
- College of Optometrists of Ontario, standards of practice
- Opto, eye health library
- American Academy of Ophthalmology, eye health
- Public Health Ontario, laboratory services test index
- CCOHS, OSH answers
- Canadian Dental Association
- Royal College of Dental Surgeons of Ontario
- CLSI, clinical and laboratory standards
- Government of Canada, medical devices guidance
- Standards Council of Canada
A plug that is not recorded cannot be reviewed later. The printable dry-eye procedure log is a blank sheet with columns for the patient, the eye, the plug type, the placement date and the review date, so a retention plan is a dated line on a page. The procedure record generator on the same page sizes the sheet to the number of lanes a clinic runs. No account and no sign-up are needed to open either one.
Every clinic layout is different. Ask a compliance specialist and you will get a written answer specific to your equipment and province, with the regulation or standard it is based on cited.
Related reading
- Artificial Tears in Canada vs the US: Which Rules Apply?
- Conjunctivitis Eye Drops in Canada vs the US: Which Rules Apply?
- Ophthalmic Refractometers in Canada vs the US: Which Class Applies?
CliniEco Medical supplies eye care, laboratory and dental consumables of the kind described in this article. MDEL #35334. This article is written for optometry, laboratory and procurement professionals and is not legal advice; the class of a device and the records kept by a clinic belong to the manufacturer and to the requirements that apply to it.
Frequently Asked Questions
Is a tear duct occluder a Class I device in the United States?
Yes. A tear duct occluder is a named Class I entry at 21 CFR 886.5838, filed under product code PLX.
How does Canada classify the same plug?
Canada names no tear duct occluder. The punctum is a body orifice, so the plug is an invasive device and Rule 2(1) places it in Class II.
When does the plug move to Class III in Canada?
When it is normally intended to remain in the body for at least 30 consecutive days. Rule 2(3) steps a long-wear invasive device up to Class III.
Does a punctal plug touch the surface of the eye?
No. It sits at or just inside the tear drainage opening, so the contact limb of Rule 2(1) is not the limb that applies. It is the body-orifice limb that applies.
What does the class change for a supplier?
A Class II device sold in Canada needs a medical device licence supported by a quality-system certificate against ISO 13485, and a Class III device carries a heavier application with review of the clinical evidence.
Does a drug-eluting plug follow the same route?
No. A plug that releases a drug is also a drug product and follows a separate route with separate evidence, in addition to the device classification.
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