Implant safety · Kisumu, Kenya
“Three people in one morning told me their eyes were writing on things”
In October 2023, a clinical officer at an aftercare clinic noticed that several of her patients were describing the same strange thing. Nineteen days later the Independent Implant Register issued a signal.
Beatrice Atieno is a clinical officer at the implant aftercare clinic run by the Lake Region Eye Trust in Kisumu, one of fourteen the Foundation funds. The clinic sees wearers of any make of optical implant, free, for check-ups, cleaning, battery tests and problems. Most of its patients have consumer implants: devices fitted to people with ordinary sight, to give them more of it.
On a Wednesday morning in October 2023, her first patient said that labels had started to stay in her vision after she looked away. Her implant could name objects it saw, a feature she used for reading signs. Now the names were lingering: she looked at a bus stop, then at the sky, and the sky said BUS STOP.
The second patient described the same thing. So did the third. “Three people in one morning told me their eyes were writing on things,” Ms Atieno says. “Different ages, different jobs, did not know each other. Same device, same week.”
The report
Each had installed a firmware update, version 7.4.0 for the SEIRAN 3, in the previous ten days. Ms Atieno filed three reports to the Independent Implant Register before lunch, using the form every aftercare clinic has on its desk. By the end of the week the Register had received 193 reports of the same symptom from clinics and wearers in four countries.
You notice a pattern when you see the same thing three times. The Register notices it when somebody writes it down.
A clinician at the Register in Chiba read each report within two days, as the Register’s rules require, and the Register’s clinical panel met on day fifteen. On day nineteen it issued a signal: a notice, published at the same moment to the public, to regulators in every country where the device is sold and to its maker, describing the fault, how to recognise it and what wearers should do. The advice was to switch off object labels until a fix was available.
The maker
The SEIRAN 3 is made by Kiroshi Opticals, the company in which the Foundation is the largest shareholder. The Register’s rules mean that the company heard about the signal at the same moment as everyone else, and no one at the Foundation with a connection to the company saw it beforehand. Kiroshi Opticals issued version 7.4.1 eight days after the signal and thanked the Register publicly. Its investigation found a fault in how the update released memory.
No one was seriously hurt. Two wearers reported minor falls, and one a near miss on a road, while their vision was full of words. The update had been installed by about 410,000 people.
The number that went up
The episode is the main reason reports to the Register rose by 14% in 2023, as the Register’s annual report explained. A rise in reports looks like bad news. In this case, the Registrar says, it was the system working: the faster people report, the faster patterns are found. Ms Atieno now trains staff at the other aftercare clinics in taking reports.