Implant safety
Optical implants are medical devices that update their own software. When one harms someone, the harm should be written down somewhere independent of the company that made it. That is what the Register is for.
- Since
- 2016, at the Chiba Centre for Visual Science
- What it records
- Harm, faults and near misses from optical implants of every make, reported by wearers, clinicians and makers
- Makers covered
- Nine, including Kiroshi Opticals and three that no longer exist
- Aftercare clinics
- Fourteen, in Japan, Kenya, the Philippines and the United States, free to wearers of any make
- FY2025 spending
- ¥2.66 billion (about US$17.5 million), 11% of charitable spending
- Registrar
- Dr Liv Marstrander, Chiba. Reports to the board’s Audit and Risk Committee
The Independent Implant Register
Anyone can report to the Register: a wearer whose implant has started to show them things that are not there, a surgeon who has removed a device that overheated, a maker that has found a fault in its own firmware. Reports are made online, by post or through any of our aftercare clinics, in Japanese, English or any language a clinic can translate. Each is read by a clinician within two working days.
The Register looks for patterns: several reports of the same fault, a rise after a firmware update, a problem that affects one batch of devices. When it finds one, which it calls a signal, it tells the maker, the regulators in every country where the device is sold and the public, at the same time and in the same words. Makers are not told first.
- Report harm from an implantBy email or post, about any make
- Every signal since 2021Device, maker, fault and outcome
- The fourteen aftercare clinicsIn Japan, Kenya, the Philippines and the United States
Because the Foundation owns a large part of one implant maker, the Register is built to be independent of the Foundation as well. The Registrar reports to the board’s Audit and Risk Committee, from which the directors nominated by Kiroshi Opticals are excluded. Its funding is set three years at a time and cannot be reduced in the middle of a term. Its annual report is published without review by anyone outside the Register.
Aftercare clinics
Fourteen clinics, run by partner hospitals, offer free check-ups, cleaning, battery and firmware checks for wearers of any make of optical implant, and report what they find to the Register. For many wearers they are the only place an implant can be looked at by someone who is not selling a replacement. In FY2025 they saw 57,930 visits.
Outcomes
The Register counts what is reported to it, which is not the same as all the harm there is. We say so, and we estimate the difference.
| Year | Reports | Serious harm | Signals issued | Median days to signal |
|---|---|---|---|---|
| FY2021 | 15,020 | 1,106 | 7 | 31 |
| FY2022 | 17,388 | 1,290 | 9 | 27 |
| FY2023 | 20,145 | 1,512 | 12 | 22 |
| FY2024 | 23,870 | 1,717 | 11 | 20 |
| FY2025 | 27,416 | 1,903 | 14 | 19 |
Serious harm: death, permanent loss of sight or other function, surgery to remove or replace the device, or a hospital stay. Signal: a pattern of reports judged by the Register’s clinical panel to show a likely fault, published with a notice to makers and regulators. Days to signal: from the first report in the pattern to publication.
More reports do not necessarily mean more harm. Reporting has risen as more people wear implants and as the clinics have made reporting easier. The Register estimates that it receives reports of between a quarter and a half of all serious harm in the countries it covers.
The Register’s own annual reports count by calendar year, so their totals differ from these.
Source: Independent Implant Register.
Recent grants
| Grant | Grantee | Amount | Awarded |
|---|---|---|---|
| KF-2025-0438 Reporting implant harm to the Register from Manila (continuation) | Manila Implant Aftercare Clinic Philippines | ¥12.8 million | 11 March 2026 |
| KF-2025-0423 Free aftercare for wearers of any make of implant in Sapporo (second phase) | Sapporo Implant Aftercare Clinic Japan | ¥53.4 million | 25 February 2026 |
| KF-2025-0261 Free aftercare for wearers of any make of implant in Chicago | Northside Implant Clinic United States | ¥46.3 million | 26 September 2025 |
| KF-2025-0220 Free aftercare for wearers of any make of implant in the San Francisco Bay Area (second phase) | Bay Area Implant Aftercare Collective United States | ¥48.5 million | 27 August 2025 |
| KF-2025-0207 Opening an aftercare clinic for wearers of any make of implant in Cebu | Cebu Island Vision Partnership aftercare clinic Philippines | ¥54.2 million | 21 August 2025 |
| KF-2025-0086 Free aftercare for wearers of any make of implant in Sendai (second phase) | Sendai Low Vision and Implant Clinic Japan | ¥47.7 million | 18 June 2025 |
All 52 grants in this programme
Stories
- “Three people in one morning told me their eyes were writing on things”Kisumu, Kenya · 2 April 2024
Programme lead: Dr Liv Marstrander, Chiba. Questions about this programme: programmes@kiroshi.org.