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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
Signals issued by the Independent Implant Register, newest first
SignalPublishedDeviceFaultReportsOutcome
S-2026-1025 October 2026Lumen 2Mirae OpticsBattery life falls below four hours after year six (batch LUM-2302)112Battery replacement programme
S-2026-0916 October 2026SEIRAN 4Kiroshi OpticalsLow-light mode switches off at crossings (firmware 6.9.6)161Fixed by firmware update
S-2026-0811 July 2026SEIRAN 3Kiroshi OpticalsPower drains overnight after an update (firmware 2.2.9)21Fixed by firmware update
S-2026-0723 June 2026AKARIKiroshi OpticalsCamera glasses lose their link to the implant in rain (batch AKA-2429)308Glasses replaced
S-2026-063 June 2026Lumen 2Mirae OpticsPower drains overnight after an update (firmware 8.8.1)260Fixed by firmware update
S-2026-0515 May 2026Lumen 2Mirae OpticsBattery swelling in one production run (batch LUM-2321)201Device recall offered
S-2026-0416 March 2026SEIRAN 4Kiroshi OpticalsScene description names people the wearer has not enrolled (firmware 2.2.1)179Fixed by firmware update
S-2026-0322 February 2026SEIRAN 4Kiroshi OpticalsConnector corrosion where the cable meets the optic nerve interface (batch SEI-2509)28Repair programme run by the maker
S-2026-029 February 2026CorvidRaven Microcybernetics (dissolved 2019)Battery swelling in one production run (batch COR-2435)306Batteries replaced through Continuity
S-2026-0128 January 2026SEIRAN 2Kiroshi OpticalsCharger pairing fails below freezing (batch SEI-2411)25Advice in force
S-2025-1118 November 2025SEIRAN 3Kiroshi OpticalsBattery fault (batch SEI-2411)312Device recall offered
S-2025-1013 November 2025Halcyon VDynalar Optics (dissolved 2018)Service connection blocked by an expired certificate (batch HAL-2424)185Fixed by Continuity documentation
S-2025-094 November 2025ClearviewOkuda BionicsText recognition reverses Japanese vertical text (firmware 4.4.5)219Fixed by firmware update
S-2025-084 November 2025Retina-SHesper MedicalInflammation around the array in a small number of wearers (batch RET-2434)145Advice in force; clinical follow-up extended
S-2025-0719 October 2025Lumen 2Mirae OpticsOverlay text drawn over the faces of people speaking (firmware 3.3.6)37Fixed by firmware update
S-2025-0611 September 2025Lumen 2Mirae OpticsBrightness surges when passing under shop lighting (batch LUM-2336)180Fixed by firmware update
S-2025-052 July 2025SEIRAN 3Kiroshi OpticalsText recognition reverses Japanese vertical text (firmware 8.9.1)71Fixed by firmware update
S-2025-0430 April 2025Retina-SHesper MedicalScene description names people the wearer has not enrolled (firmware 5.7.4)18Fixed by firmware update
S-2025-0325 April 2025SEIRAN 2Kiroshi OpticalsCharging coil overheats on third-party chargers (batch SEI-2240)221Advice in force: use the original charger
S-2025-0210 April 2025CorvidRaven Microcybernetics (dissolved 2019)Image freezes for several seconds on waking (firmware 3.7.1)38Advice in force
S-2025-0130 March 2025ClearviewOkuda BionicsImage freezes for several seconds on waking (firmware 3.6.4)30Fixed by firmware update
S-2024-1326 December 2024ClearviewOkuda BionicsCharging coil overheats on third-party chargers (batch CLE-2206)334Fixed by charger replacement
S-2024-1220 November 2024SEIRAN 3Kiroshi OpticalsBrightness surges when passing under shop lighting (batch SEI-2314)236Fixed by firmware update
S-2024-1125 October 2024SEIRAN 2Kiroshi OpticalsHousing seal fails after swimming (batch SEI-2122)259Advice in force
S-2024-1013 September 2024Lumen 2Mirae OpticsConnector corrosion where the cable meets the optic nerve interface (batch LUM-2325)147Repair programme run by the maker
S-2024-0918 August 2024CorvidRaven Microcybernetics (dissolved 2019)Service connection blocked by an expired certificate (batch COR-2335)80Fixed by Continuity documentation
S-2024-0824 July 2024ClearviewOkuda BionicsColour shift towards blue after twelve months (batch CLE-2334)22Advice in force
S-2024-071 July 2024LR-3Lindgren RetinalMagnification setting resets to maximum (firmware 7.8.3)52Fixed by firmware update
S-2024-064 June 2024Lumen 2Mirae OpticsHousing seal fails after swimming (batch LUM-2129)58Advice in force; seal redesigned
S-2024-0514 April 2024Lumen 2Mirae OpticsLow-light mode switches off at crossings (firmware 5.7.8)51Fixed by firmware update
S-2024-048 April 2024SEIRAN 4Kiroshi OpticalsCharger pairing fails below freezing (batch SEI-2104)313Advice in force
S-2024-032 March 2024SEIRAN 3Kiroshi OpticalsFalse obstacle warnings on stairs (batch SEI-2215)50Fixed by firmware update
S-2024-0219 February 2024SEIRAN 2Kiroshi OpticalsBattery swelling in one production run (batch SEI-2107)68Device recall offered
S-2024-0130 January 2024Iris 1Ono-SendaiCharging coil overheats on third-party chargers (batch IRI-2104)383Advice in force: use the original charger
S-2023-128 December 2023CorvidRaven Microcybernetics (dissolved 2019)Device will not wake after a battery fully drains (batch COR-2026)242Recovery tool published through Continuity
S-2023-1124 November 2023CorvidRaven Microcybernetics (dissolved 2019)Night-time heat from the processor disturbs sleep (batch COR-2023)321Advice in force
S-2023-106 November 2023SEIRAN 3Kiroshi OpticalsObject labels persist in vision after firmware 7.4.0846Fixed by firmware 7.4.1. How a clinic found it
S-2023-093 November 2023CorvidRaven Microcybernetics (dissolved 2019)Charger pairing fails below freezing (batch COR-2037)32Advice in force
S-2023-087 October 2023SEIRAN 2Kiroshi OpticalsHeadaches linked to a refresh-rate change (firmware 6.5.8)20Fixed by firmware update
S-2023-0728 August 2023SEIRAN 2Kiroshi OpticalsConnector corrosion where the cable meets the optic nerve interface (batch SEI-2226)65Repair programme run by the maker
S-2023-0623 August 2023ClearviewOkuda BionicsContrast falls sharply in low light after an update (firmware 8.3.5)21Fixed by firmware update
S-2023-0519 June 2023Retina-SHesper MedicalPhosphenes appear in the wrong place after re-tuning (batch RET-2115)18Re-tuning procedure revised
S-2023-042 May 2023Lumen 2Mirae OpticsMagnification setting resets to maximum (firmware 8.3.0)177Fixed by firmware update
S-2023-0330 March 2023SEIRAN 3Kiroshi OpticalsHeadaches linked to a refresh-rate change (firmware 4.3.3)419Update withdrawn
S-2023-0213 March 2023SEIRAN 2Kiroshi OpticalsDevice will not wake after a battery fully drains (batch SEI-2214)151Fixed at clinics with a recovery tool
S-2023-0110 February 2023SEIRAN 2Kiroshi OpticalsOverlay text drawn over the faces of people speaking (firmware 7.8.4)240Fixed by firmware update
S-2022-0717 November 2022CorvidRaven Microcybernetics (dissolved 2019)Connector corrosion where the cable meets the optic nerve interface (batch COR-1930)18Repairs through Continuity; new connector design commissioned
S-2022-0627 October 2022SEIRAN 3Kiroshi OpticalsColour shift towards blue after twelve months (batch SEI-1907)18Sensor replaced under warranty
S-2022-0519 July 2022CorvidRaven Microcybernetics (dissolved 2019)Battery life falls below four hours after year six (batch COR-2025)260Batteries replaced through Continuity
S-2022-048 July 2022SEIRAN 3Kiroshi OpticalsScene description names people the wearer has not enrolled (firmware 5.8.7)27Fixed by firmware update
S-2022-0316 June 2022CorvidRaven Microcybernetics (dissolved 2019)Colour shift towards blue after twelve months (batch COR-1927)95Advice in force
S-2022-0218 April 2022Lumen 2Mirae OpticsColour shift towards blue after twelve months (batch LUM-1937)37Advice in force
S-2022-0127 January 2022SEIRAN 3Kiroshi OpticalsOverlay text drawn over the faces of people speaking (firmware 6.1.8)102Fixed by firmware update
S-2021-066 December 2021SEIRAN 3Kiroshi OpticalsCharging coil overheats on third-party chargers (batch SEI-1917)127Fixed by charger replacement
S-2021-052 December 2021SEIRAN 3Kiroshi OpticalsHousing seal fails after swimming (batch SEI-2001)178Advice in force; seal redesigned
S-2021-047 November 2021CorvidRaven Microcybernetics (dissolved 2019)Sensor drift causing double vision (batch COR-1824)72Repairs through Continuity
S-2021-038 October 2021SEIRAN 3Kiroshi OpticalsSensor drift causing double vision (batch SEI-1816)104Repair programme run by the maker
S-2021-029 September 2021SEIRAN 3Kiroshi OpticalsNight-time heat from the processor disturbs sleep (batch SEI-2020)380Charging schedule changed by update
S-2021-0122 April 2021SEIRAN 3Kiroshi OpticalsContrast falls sharply in low light after an update (firmware 4.0.6)21Fixed by firmware update

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.