Implant safety
Signals
A signal is the Register’s public notice that a pattern of reports shows a likely fault. Each is published to the public, to regulators in every country where the device is sold and to its maker, at the same moment. These are all 59 signals issued since 1 April 2021.
Signals
| Signal | Published | Device | Fault | Reports | Outcome | More |
|---|---|---|---|---|---|---|
| S-2026-09 | 5 September 2026 | SEIRAN 4Kiroshi Opticals | Connector corrosion where the cable meets the optic nerve interface | 18 | Repair programme run by the maker | None |
| S-2026-08 | 6 August 2026 | SEIRAN 3Kiroshi Opticals | Battery life falls below four hours after year six | 83 | Battery replacement programme | None |
| S-2026-07 | 4 August 2026 | Retina-SHesper Medical | Inflammation around the array in a small number of wearers | 311 | Advice in force; clinical follow-up extended | None |
| S-2026-06 | 23 July 2026 | SEIRAN 2Kiroshi Opticals | Colour shift towards blue after twelve months | 27 | Advice in force | None |
| S-2026-05 | 13 June 2026 | Iris 1Ono-Sendai | Night-time heat from the processor disturbs sleep | 33 | Advice in force | None |
| S-2026-04 | 9 April 2026 | AKARIKiroshi Opticals | Camera glasses lose their link to the implant in rain | 167 | Glasses replaced | None |
| S-2026-03 | 19 March 2026 | CorvidRaven Microcybernetics (dissolved 2019) | Battery swelling in one production run | 273 | Batteries replaced through Continuity | None |
| S-2026-02 | 16 February 2026 | CorvidRaven Microcybernetics (dissolved 2019) | Connector corrosion where the cable meets the optic nerve interface | 330 | Repairs through Continuity; new connector design commissioned | None |
| S-2026-01 | 14 January 2026 | Iris 1Ono-Sendai | Charger pairing fails below freezing | 259 | Advice in force | None |
| S-2025-13 | 18 November 2025 | SEIRAN 3Kiroshi Opticals | Battery fault in one production run | 312 | Device recall offered | None |
| S-2025-12 | 13 November 2025 | Halcyon VDynalar Optics (dissolved 2018) | Service connection blocked by an expired certificate | 163 | Fixed by Continuity documentation | None |
| S-2025-11 | 12 November 2025 | SEIRAN 2Kiroshi Opticals | Charging coil overheats on third-party chargers | 37 | Advice in force: use the original charger | None |
| S-2025-10 | 13 September 2025 | Lumen 2Mirae Optics | Connector corrosion where the cable meets the optic nerve interface | 176 | Repair programme run by the maker | None |
| S-2025-09 | 9 September 2025 | SEIRAN 4Kiroshi Opticals | Scene description names people the wearer has not enrolled | 225 | Fixed by firmware update | None |
| S-2025-08 | 30 August 2025 | CorvidRaven Microcybernetics (dissolved 2019) | Battery life falls below four hours after year six | 18 | Batteries replaced through Continuity | None |
| S-2025-07 | 18 August 2025 | CorvidRaven Microcybernetics (dissolved 2019) | Service connection blocked by an expired certificate | 322 | Fixed by Continuity documentation | None |
| S-2025-06 | 12 August 2025 | Retina-SHesper Medical | Electrode array moves in the first year after fitting | 23 | Surgical guidance revised | None |
| S-2025-05 | 1 July 2025 | LR-3Lindgren Retinal | Flicker in bright sunlight after a camera update | 21 | Fixed by firmware update | None |
| S-2025-04 | 14 April 2025 | Lumen 2Mirae Optics | Low-light mode switches off at crossings | 282 | Fixed by firmware update | None |
| S-2025-03 | 8 April 2025 | SEIRAN 4Kiroshi Opticals | Charger pairing fails below freezing | 21 | Advice in force | None |
| S-2025-02 | 30 January 2025 | Iris 1Ono-Sendai | Charging coil overheats on third-party chargers | 21 | Advice in force: use the original charger | None |
| S-2025-01 | 13 January 2025 | ClearviewOkuda Bionics | Scene description names people the wearer has not enrolled | 383 | Fixed by firmware update | None |
| S-2024-10 | 20 December 2024 | LR-3Lindgren Retinal | Stimulation thresholds rise, dimming what the wearer sees | 183 | Advice in force | None |
| S-2024-09 | 21 November 2024 | SEIRAN 3Kiroshi Opticals | False obstacle warnings on stairs | 126 | Fixed by firmware update | None |
| S-2024-08 | 18 September 2024 | SEIRAN 3Kiroshi Opticals | Charging coil overheats on third-party chargers | 67 | Fixed by charger replacement | None |
| S-2024-07 | 17 August 2024 | CorvidRaven Microcybernetics (dissolved 2019) | Clock fault resets settings every 28 days | 43 | Workaround published through Continuity | None |
| S-2024-06 | 6 July 2024 | SEIRAN 3Kiroshi Opticals | Power drains overnight after an update | 379 | Fixed by firmware update | None |
| S-2024-05 | 26 June 2024 | SEIRAN 3Kiroshi Opticals | Device will not wake after a battery fully drains | 396 | Fixed at clinics with a recovery tool | None |
| S-2024-04 | 24 June 2024 | SEIRAN 4Kiroshi Opticals | Battery swelling in one production run | 25 | Battery replacement programme | None |
| S-2024-03 | 4 May 2024 | SEIRAN 2Kiroshi Opticals | Housing seal fails after swimming | 58 | Advice in force | None |
| S-2024-02 | 9 April 2024 | Lumen 2Mirae Optics | Battery life falls below four hours after year six | 121 | Battery replacement programme | None |
| S-2024-01 | 12 March 2024 | SEIRAN 2Kiroshi Opticals | Device will not wake after a battery fully drains | 66 | Fixed at clinics with a recovery tool | None |
| S-2023-15 | 23 December 2023 | AKARIKiroshi Opticals | Scene description names people the wearer has not enrolled | 156 | Fixed by firmware update | None |
| S-2023-14 | 15 November 2023 | SEIRAN 3Kiroshi Opticals | Housing seal fails after swimming | 24 | Advice in force; seal redesigned | None |
| S-2023-13 | 11 November 2023 | SEIRAN 2Kiroshi Opticals | Power drains overnight after an update | 155 | Fixed by firmware update | None |
| S-2023-12 | 6 November 2023 | SEIRAN 3Kiroshi Opticals | Object labels persist in vision after firmware 7.4.0 | 846 | Fixed by firmware 7.4.1 | Story |
| S-2023-11 | 27 October 2023 | SEIRAN 3Kiroshi Opticals | Colour shift towards blue after twelve months | 29 | Advice in force | None |
| S-2023-10 | 18 August 2023 | ClearviewOkuda Bionics | Colour shift towards blue after twelve months | 147 | Sensor replaced under warranty | None |
| S-2023-09 | 13 August 2023 | ClearviewOkuda Bionics | Charging coil overheats on third-party chargers | 273 | Fixed by charger replacement | None |
| S-2023-08 | 31 July 2023 | SEIRAN 2Kiroshi Opticals | Battery life falls below four hours after year six | 62 | Battery replacement programme | None |
| S-2023-07 | 12 June 2023 | SEIRAN 3Kiroshi Opticals | Text recognition reverses Japanese vertical text | 410 | Fixed by firmware update | None |
| S-2023-06 | 2 May 2023 | Lumen 2Mirae Optics | Magnification setting resets to maximum | 78 | Fixed by firmware update | None |
| S-2023-05 | 27 April 2023 | SEIRAN 2Kiroshi Opticals | Low-light mode switches off at crossings | 70 | Fixed by firmware update | None |
| S-2023-04 | 30 March 2023 | SEIRAN 3Kiroshi Opticals | Headaches linked to a refresh-rate change | 58 | Fixed by firmware update | None |
| S-2023-03 | 27 February 2023 | SEIRAN 3Kiroshi Opticals | Charger pairing fails below freezing | 59 | Advice in force | None |
| S-2023-02 | 11 February 2023 | SEIRAN 3Kiroshi Opticals | Connector corrosion where the cable meets the optic nerve interface | 175 | Repair programme run by the maker | None |
| S-2023-01 | 27 January 2023 | SEIRAN 3Kiroshi Opticals | Overlay text drawn over the faces of people speaking | 30 | Fixed by firmware update | None |
| S-2022-05 | 7 November 2022 | Lumen 2Mirae Optics | Brightness surges when passing under shop lighting | 37 | Fixed by firmware update | None |
| S-2022-04 | 28 July 2022 | Lumen 2Mirae Optics | Charging coil overheats on third-party chargers | 288 | Fixed by charger replacement | None |
| S-2022-03 | 8 July 2022 | SEIRAN 3Kiroshi Opticals | Scene description names people the wearer has not enrolled | 302 | Fixed by firmware update | None |
| S-2022-02 | 16 June 2022 | CorvidRaven Microcybernetics (dissolved 2019) | Colour shift towards blue after twelve months | 207 | Advice in force | None |
| S-2022-01 | 18 April 2022 | Lumen 2Mirae Optics | Colour shift towards blue after twelve months | 360 | Advice in force | None |
| S-2021-07 | 15 December 2021 | AKARIKiroshi Opticals | Phosphenes appear in the wrong place after re-tuning | 208 | Re-tuning procedure revised | None |
| S-2021-06 | 9 November 2021 | Lumen 2Mirae Optics | Contrast falls sharply in low light after an update | 56 | Fixed by firmware update | None |
| S-2021-05 | 7 November 2021 | CorvidRaven Microcybernetics (dissolved 2019) | Sensor drift causing double vision | 160 | Repairs through Continuity | None |
| S-2021-04 | 13 August 2021 | Retina-SHesper Medical | Scene description names people the wearer has not enrolled | 54 | Fixed by firmware update | None |
| S-2021-03 | 8 August 2021 | SEIRAN 3Kiroshi Opticals | Night-time heat from the processor disturbs sleep | 403 | Charging schedule changed by update | None |
| S-2021-02 | 8 May 2021 | AKARIKiroshi Opticals | Magnification setting resets to maximum | 409 | Fixed by firmware update | None |
| S-2021-01 | 22 April 2021 | SEIRAN 3Kiroshi Opticals | Contrast falls sharply in low light after an update | 19 | Fixed by firmware update | None |
Reports: the number of reports in the pattern when the signal was published. Signals before April 2021 are listed in the Register’s annual reports.