A Cataract Surgeon’S Nightmare: Eyecee One Intraocular Lens Recall And Elevated Intraocular Pressure Unresponsive To Medical Management

The EyeCee One preloaded intraocular lenses (EC1 IOL) and the EC1 Crystal preloaded IOLs (EC1C IOL) were withdrawn in the United Kingdom (UK) on the 26 January 2023, following reports of raised intraocular pressure (IOP) from October 2022.  A Field Safety Notice (NIDEK, Japan, the manufacturer) and a Device Safety Information notification DSI/2023/001 (Medicine and Healthcare products Regulatory Agency UK (MHRA)) were issued on 26 January 2023 advising to discontinue use of the IOLs and quarantine them.  This study aimed to describe the management and preliminary outcomes for the eyes requiring procedures in addition to medical therapy for IOP control.

A tertiary centre in the UK using EC1 IOLs identified all patients affected, between 1 October 2022 – 26 January 2023, as specified by the National Patient Safety Alert issued by the MHRA (NatPSA/2023/003/MHRA) on 1 February 2023. Following risk assessment and Directorate discussion, the decision was made to recall all affected patients for a face-to-face review. EC1C IOLs were not used in this unit. Given the recency of events, this is an evolving dataset.

This was a retrospective case series including all patients in a single UK tertiary centre receiving the EC1 IOL between 1 October 2022 – 26 January 2023, inclusive, who required procedures additional to medical therapy for IOP control. Cases were identified via the electronic patient record (Medisoft Ltd, Leeds, UK). Preliminary outcomes are reported.

There were 819 eyes (757 patients). Three (0.4%) eyes required surgery (TrabEx+, trabeculectomy, anterior chamber washout, IOL exchange with pars plana vitrectomy) and slit lamp procedures. One (0.1%) eye required slit lamp wound decompression. Ocular co-morbidities were primary angle closure suspect, glaucoma with traumatic angle recession, Fuch’s corneal endothelial dystrophy. The median baseline, highest, and latest IOPs were 14.6 (12.7-34.9) mmHg, 62.9 (54.0-80.0) mmHg, and 16.8 (14.5-22.0) mmHg, respectively. To date, the median follow-up time was 80.5 (48-123) days. The IOP remains uncontrolled in 2 eyes. Both await further surgery.

The IOP problems associated with the affected EC1 IOLs were unknown prior to 26 January 2023, impacting the surgical management of the eyes. The recency of the EC1 IOL withdrawal means the dataset is evolving. Our data suggests that those with abnormal angles may be susceptible to more severe IOP problems from the affected EC1 IOL. The eye with IOL exchange requires further glaucoma surgery for IOP control. The authors acknowledge this is only 1 eye, but this case suggests that IOL exchange does not guarantee IOP control.