Quick facts
- A scleral shell is a thin glass or plastic cover worn over a blind or shrunken eye, made to match the other eye and restore the look of the socket.
- United States: the shell is reached as a scleral shell at 21 CFR 886.3800, placed in Class II; the entry states that the device is exempt from premarket notification.
- Canada: the shell comes into contact with the surface of the eye, so it reaches Class II through Rule 2(1) of Schedule 1 to the Medical Devices Regulations, SOR/98-282, which clasps an invasive device that contacts the surface of the eye.
- The two countries land on the same class: Class II in the United States and Class II in Canada, by different machinery.
- A shell worn only by day is not held to Class III, which Rule 2(3) reserves for a device normally intended to remain in contact with the surface of the eye for at least 30 consecutive days.
- The entry and rule text below were checked against the current CFR text and the Regulations on 2026-10-09.
A scleral shell is the cosmetic cover worn over an eye that can no longer see. It is made to sit on the globe, or on the sclera around a shrunken eye, and to match the fellow eye in colour, size and lid contour. It is worn by day and removed at night, and it contacts the surface of the eye while it is worn. That contact is the fact both rulebooks act on. This article sets out what the shell does, how each country files it, and what a practice should be able to point at when the shell is fitted and when it is cleaned.
What is a scleral shell?
The shell is a thin moulded cover, commonly made of glass or of a plastic such as PMMA, that rests over the anterior globe or the shrunken remnant of an eye. It is painted to match the fellow iris and sclera, and it is shaped so that the lids close over it naturally. The thickness at the rim, the fit over the globe and the painted iris are the three settings that decide how the shell looks and how it wears.
The shell is not an implant and it is not a contact lens for vision. It does not correct sight, and it does not sit on a healthy cornea for optical reasons. It covers the surface of the eye, and that is the fact the rules act on in both countries.
How does the United States file a scleral shell?
In the United States the shell is reached by a named entry. 21 CFR 886.3800 covers a scleral shell, and the section places it in Class II. The entry describes a device made of glass or plastic that is intended to be inserted for short time periods over the cornea and the proximal-cornea sclera for cosmetic purposes, and it states that the device is exempt from premarket notification.
A Class II device of this kind reaches the market under general and special controls. The entry turns on the short periods of wear and on the cosmetic purpose, so a shell worn for a part of each day is the article the entry describes rather than a device left in place.
Why does Canada reach Class II by rule?
Canada classifies the shell through the invasive-device rules in Schedule 1. Rule 2(1) puts all invasive devices that penetrate the body through a body orifice, or that come into contact with the surface of the eye, in Class II. A scleral shell comes into contact with the surface of the eye, so it falls to that rule and reaches Class II.
The two subrules that lift the class do not describe a shell worn by day. Rule 2(3) lifts the class to Class III for a device normally intended to remain in contact with the surface of the eye for at least 30 consecutive days, and a shell removed each night is not that device. Rule 2(2) lowers a device placed in the oral or nasal cavity as far as the pharynx, or in the ear canal to the drum, to Class I, which does not describe an ocular shell.
| Item | Canada | United States |
|---|---|---|
| Class | Class II, by Rule 2(1) | Class II |
| Named entry | No entry names the shell; it is an invasive eye device | 21 CFR 886.3800 |
| Basis of the class | The rule that fits a device contacting the surface of the eye | The named entry the shell is filed under |
| Wear pattern | Short periods, removed nightly | Short periods, over the cornea and proximal sclera |
| Premarket route | Device licence under section 32 for a Class II device | General and special controls, exempt from premarket notification |
| Quality system | CAN/CSA-ISO 13485 certificate behind the licence | Quality system regulation |
The two countries agree on the class and disagree on the machinery: the United States names the shell and Canada reaches it through the invasive rule for an eye device. A practice that keeps the maker's fitting and cleaning instructions with the shell has the document the class implies.
Which standards sit behind the shell?
The class says how the shell is regulated; the standards say how it has to behave. ISO 13485:2016 is the quality management basis behind the licence, and ISO 14971:2019 is the risk management basis behind the design file. A practice that asks for those two documents is asking for the evidence behind the fit the shell claims.
| Element | What it covers | Why it matters at the chair |
|---|---|---|
| Fit | How the shell sits on the globe | A shell that lifts at the rim collects debris |
| Thickness | The weight at the rim | A heavy rim settles and rubs the socket |
| Painted iris | Colour and pupil size | A mismatch is the flaw a patient notices first |
| Surface | The finish against the tissue | A rough surface irritates the socket lining |
| Sterile supply | The pack the shell arrives in | The pack is what keeps the shell clean until fitting |
| Cleaning | The step between wear periods | The step that keeps the shell wearable |
A shell that cannot show its fitting and a socket that cannot be traced to the shell worn in it are the two gaps that meet in the same clinic.
What happens at a scleral shell fitting?
A scleral shell is made to a socket rather than picked from a shelf, so the fitting is a moulding step before it is a dispensing step. The ocularist takes an impression of the socket, matches the colour of the fellow eye, and shapes the shell so that the lids close over it and the rim sits without rocking. The fit and the painted iris are reviewed after the tissue has settled, because swelling changes the space the shell fills.
The fitting record is the document that ties the shell to the socket. It carries the patient, the shell, the fitting date and the review, and it is the record a clinic keeps for the shell as a device that touches the surface of the eye.
What else sits beside the shell?
An ocular practice stocks the service as a set. A post-operative eye patch set is the dressing line used around the socket, and a multipurpose contact lens solution is the care step used for the lenses fitted alongside. Clinics that monitor their own reprocessing pair the sterilization monitoring collection with the 24-hour biological indicator 50-pack. 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.
Sources
- 21 CFR 886.3800, scleral shell
- openFDA device classification API
- Medical Devices Regulations, SOR/98-282, full text and Schedule 1
- US FDA, medical devices
- US FDA, medical device databases
- US FDA, overview of device regulation
- Health Canada, medical devices
- Standards Council of Canada
- CSA Group
- ISO 13485:2016, medical devices quality management
- ISO 14971:2019, risk management of medical devices
- Canadian Association of Optometrists
- College of Optometrists of Ontario
- CCOHS, OSH answers
- American National Standards Institute
- US FDA, contact lenses
A scleral shell is followed on a fitting record, because the shell is made to a socket rather than bought off a shelf. The printable ocular fitting and cleaning log is a blank sheet with columns for the patient, the shell, the fitting date, the cleaning step and the review, so a clinic can reconcile the shell it dispensed with the socket it was made for.
The ocular fitting log generator on the same page sizes the sheet to the number of fittings a practice books, so a single ocularist and a multi-site group print the form at the volumes they need.
Every practice and every socket differs. 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
- Contact lens solution in Canada vs the US: which rules apply
- Eye shields in Canada vs the US: which device rules
- Contact lens conversion charts in Canada vs the US: which rules
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 practice belong to the manufacturer and to the requirements that apply to it.
Frequently Asked Questions
What class is a scleral shell in Canada?
It comes into contact with the surface of the eye, so it reaches Class II through Rule 2(1) of Schedule 1 to the Medical Devices Regulations.
What class is a scleral shell in the United States?
It is a named entry at 21 CFR 886.3800 in Class II, and the entry states that the device is exempt from premarket notification.
Do the two countries agree on the class?
Yes. The shell is Class II in the United States and Class II in Canada, reached by a named entry on one side and by the invasive rule on the other.
When would an eye device become Class III in Canada?
Rule 2(3) lifts an invasive eye device to Class III where it is normally intended to remain in contact with the surface of the eye for at least 30 consecutive days, which does not describe a shell removed each night.
Is a scleral shell the same as an implant?
No. A shell is a removable cover worn over the globe, while an implant is a device placed within the socket. The two are separate articles with separate records.
Does a scleral shell correct vision?
No. The shell is fitted for appearance rather than for sight, and it is made to match the fellow eye rather than to carry a prescription.
What should a practice keep with a scleral shell?
The fitting record and the maker's cleaning instructions, so the shell can be traced to the socket it was made for and the care step between wear periods is written down.
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