Quick facts
- After enucleation or evisceration an orbital implant or eye sphere fills the socket, and a conformer holds the socket shape until a prosthesis is fitted.
- In the United States these devices file under 21 CFR 886.3320, Implant, eye sphere and its orbital-implant siblings, at Class II, and under 21 CFR 886.3130 for ophthalmic conformers, also Class II.
- A non-custom artificial eye is a separate, lower entry: 21 CFR 886.3200 at Class I.
- In Canada a permanent orbital implant is a surgically invasive device that stays in the body, so Rule 1(3) of Schedule 1 sets Class III; a removable artificial eye is non-invasive and sits at Class I under Rule 7(1).
- A conformer worn for at least 30 consecutive days follows the implant route to Class III, not the Class I route.
- Entries, classes and product codes below were checked against the eCFR, the Regulations and the openFDA classification database on 2026-10-12.
When an eye is removed, two objects take its place. The first is the orbital implant - a sphere of porous plastic, hydroxyapatite or glass that is sutured into the socket and stays for life. The second is the conformer, a clear shell worn for the weeks between surgery and the fitting of a prosthesis, and the artificial eye itself, which is removable. The three are often ordered together but they do not share a class, in the United States or in Canada. This article sets out which entry each one files under, how the Canadian rules separate them, and what a clinic records. The sterile disposable bed sheets used in the same recovery bay are ordered on the same requisition.
What is an orbital implant, a conformer and an artificial eye?
An orbital implant (also called an eye sphere) is a solid or porous ball placed in the socket after enucleation or evisceration, usually with the extraocular muscles attached so that it moves with the remaining eye. A conformer is a thin, clear shell inserted at the end of surgery to keep the socket open and shaped while the tissue heals; it is changed or removed before the prosthesis is made. An artificial eye is the visible prosthesis the patient wears afterwards, made to match the fellow eye and removed nightly for cleaning.
The classification turns on one question: does the device remain inside the body? The implant does - for life. The conformer is worn in the socket for weeks to months, and a rule that counts consecutive days catches it. The artificial eye is a removable prosthesis that does not enter the body, so a different rule applies to it.
That question is not academic for a purchasing officer, because the three items are often on one requisition. A socket set bought as a single line reads as one class on the order form and is three different classes in fact, which is the kind of gap an audit finds first. Writing each item on its own line, with its own class, closes it.
Which US entries cover these devices?
Three regulation numbers cover the family. 21 CFR 886.3320, Implant, eye sphere, is a Class II entry and the openFDA classification API lists Implant, Eye Sphere (HPZ), Wrap, Implant, Orbital (MTZ) and Expander, Tissue, Orbital (NFM) under it. 21 CFR 886.3130, for ophthalmic conformers, is also Class II. A non-custom artificial eye is lighter still: 21 CFR 886.3200 is a Class I entry, product code HQH.
The pattern is worth reading carefully. The implant is an internal device and carries the heavier controls; the conformer is a temporary internal device and still sits at Class II; the artificial eye, which never enters the body, is Class I. A clinic that buys all three on one order should not assume one class covers the lot.
| Device | US regulation | US class | Product code |
|---|---|---|---|
| Orbital implant / eye sphere | 21 CFR 886.3320 | II | HPZ, MTZ, NFM |
| Ophthalmic conformer | 21 CFR 886.3130 | II | HQN |
| Artificial eye (non-custom) | 21 CFR 886.3200 | I | HQH |
| Iris button for an artificial eye | 21 CFR 886.3200 | I | NCK |
How does Canada classify each one?
Canada applies Schedule 1 of the Medical Devices Regulations. A permanent orbital implant is a surgically invasive device that normally remains in the body for at least 30 consecutive days, so Rule 1(3) sets Class III. A conformer worn past 30 days follows the same route. A removable artificial eye does not enter the body, so Rule 7(1) places it at Class I - the same general default that covers any other non-invasive device.
This is where a reader who expects one Canadian class for the whole family gets caught. The implant and the conformer are Class III; the prosthesis is Class I. A purchase order that puts them on the same line and writes a single class beside it is wrong for at least one of them.
| Device | Canada | United States |
|---|---|---|
| Orbital implant / eye sphere | Class III (Rule 1(3)) | Class II (886.3320) |
| Conformer worn 30 days or more | Class III (Rule 1(3)) | Class II (886.3130) |
| Artificial eye (removable) | Class I (Rule 7(1)) | Class I (886.3200) |
| Governing text | Schedule 1, Rules 1 and 7 | 21 CFR 886.3320 / 886.3130 / 886.3200 |
| Route to market | Device licence for Class III; none for Class I | 510(k) for Class II; registration for Class I |
What does a void or a low-count record look like?
The records differ by class again. A Class III implant needs a device licence under section 32 and a dossier that includes ISO 13485 quality certification, ISO 14971 risk management and biocompatibility data under ISO 10993-1. The artificial eye, at Class I, needs no device licence of its own; the manufacturer holds an establishment licence and keeps distribution records.
For the clinic the practical obligation is the same in both cases: keep the implant lot label with the operative note, record the conformer size and the dates it was worn, and store the prosthesis clean and protected. Those three lines are what a reviewer asks for when a socket outcome is questioned later.
Which materials and standards sit behind an orbital implant?
Socket implants are made from porous polyethylene, hydroxyapatite, aluminium oxide or glass, and the surface is designed so that tissue grows into it and the muscles can be attached. Every material in contact with tissue is evaluated under ISO 10993-1. A conformer is often medical-grade acrylic or a thermoplast; it is a short-term contact device but it still contacts mucous membrane, so the same biocompatibility question is asked of it, at a lower intensity.
Sterilisation and packaging follow the general implant standards. Eto sterilisation is governed by ISO 11135 and the sterile barrier by ISO 11607-1. As with any implant, the clinic does not re-sterilise; it inspects the pack, reads the expiry and records the lot.
How should the order be written?
Write each device on its own line with the class that applies to it. The implant and the conformer carry a Class III statement in Canada and a 510(k) reference in the United States; the artificial eye is a Class I item that needs no device licence in Canada. Name the material, the size and the lot for the implant, the size and the wear period for the conformer, and the fitting date for the prosthesis.
There is a second reason to keep them apart. The implant and the conformer are surgically supplied items that arrive sterile; the prosthesis is a made-to-measure device that is fitted and then maintained at home. The storage, handling and replacement rules differ for the same reason the classes differ, and one order line that hides all three makes it harder to apply the right rule to the right object.
A socket-care stock list mixes sterile implants with clean-handling items. Clinics that stock for a whole practice can order through the wholesale programme and request a bulk quote for a standing or annual order; the birch wood tongue depressors, 100 pack sits in the same catalogue. Reselling? become a distributor.
Sources
- openFDA device classification API
- Medical Devices Regulations, SOR/98-282, full text and Schedule 1
- US FDA, overview of device regulation
- US FDA, medical device databases
- Health Canada, medical devices
- Health Canada, establishment licensing
- ISO 10993-1:2018, biological evaluation of medical devices
- ISO 13485:2016, medical devices quality management
- ISO 14971:2019, risk management of medical devices
- ISO 11135:2014, ethylene oxide sterilization of medical devices
- ISO 11607-1:2019, packaging for terminally sterilized medical devices
- ISO 15004-1:2020, ophthalmic instruments, general requirements
- Public Health Ontario, infection prevention and control
- Canadian Association of Optometrists
- College of Optometrists of Ontario, standards of practice
Printable record sheet. An oculoplastic list generates its own paperwork: implant lots, conformer sizes, healing checks. Open the free sterilization log sheet library — the downloadable pack holds a steam-cycle log, a reprocessing-room checklist and an equipment-maintenance sheet. No account and no sign-up; print as many copies as your autoclave log needs.
Log generator. Because a socket-care room keeps a stock and cleaning log alongside the surgical record. Run the sterilization log generator to build a dated, facility-labelled cycle sheet you can print or file straight into your quality manual.
Ask a compliance specialist. If you stock socket implants and conformers and want a record that lines up with the class of each item. Send your question — you get a written answer specific to your equipment and province, with the regulation or standard it is based on cited.
Related reading
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 dental procurement professionals and is not legal advice; the class of a device and the records a practice keeps belong to the manufacturer and to the requirements that apply to it.
Frequently Asked Questions
What is the difference between an orbital implant, a conformer and an artificial eye?
The implant is a permanent sphere placed in the socket at surgery; the conformer is a temporary shell that holds the socket shape while it heals; the artificial eye is the removable prosthesis the patient wears afterwards.
What class is an orbital implant in the United States?
Class II. It is filed under 21 CFR 886.3320 (Implant, eye sphere), with product codes such as HPZ, MTZ and NFM.
Why is the same implant Class III in Canada?
Rule 1(3) of Schedule 1 sets Class III for a surgically invasive device normally intended to remain in the body for at least 30 consecutive days. An orbital implant is a lifelong implant.
Is an artificial eye Class I in Canada?
Yes. A removable artificial eye does not enter the body, so Rule 7(1) places it at Class I - the same class as the US entry at 21 CFR 886.3200.
How long can a conformer be worn before it changes class?
A conformer intended to stay in place for at least 30 consecutive days is treated like the implant under Rule 1(3) and is Class III, not Class I. Shorter-term use is a different question and should follow the manufacturer's stated wear period.
What records should the clinic keep?
The implant lot with the operative note, the conformer size and wear dates, and the prosthesis fitting date. Those three lines are what a reviewer checks when a socket outcome is reviewed.
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