Eyecee One Preloaded Intraocular Lens Recall: Preliminary Report Of Outcomes In A Large United Kingdom Tertiary Hospital Cohort Of 819 Eyes

The EyeCee One preloaded intraocular lenses (EC1 IOL) and the EC1 Crystal preloaded IOLs (EC1C IOL) were withdrawn in the United Kingdom (UK) on the 26 January 2023, following reports of raised intraocular pressure (IOP) from October 2022.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 report the outcomes of the affected patients and actions taken to rectify any IOP rise resulting from implantation of these. 

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 cohort study including all patients in a single UK tertiary centre receiving the EC1 IOL between 1 October 2022 – 26 January 2023, inclusive. Cases were identified via the electronic patient record (Medisoft Ltd, Leeds, UK). Eyes were grouped based on initial post-operative IOP (median 2 (0-18) weeks):  Group A <22mmHg, Group B 22-29 mmHg, Group C 30-39mmHg, Group D >/= 40mmHg. Primary outcomes were the change in post-operative IOP from baseline and the need for additional intervention. Change in visual acuity, demographic data, ocular co-morbidity, biometry, intra-operative complications, and post-operative complications were examined. Preliminary outcomes to a median 14 (6.3-22.4) weeks post-operative are reported

There were 819 eyes, 757 patients. The median IOPs were: Group A 14.5 (1.0 - 21.9) mmHg, Group B 23.7 (22.0 - 29.7) mmHg, Group C 34.3 (30.0 - 39.8) mmHg, Group D 48.5 (40.0 - 65.4) mmHg. Raised IOP from baseline occurred in 444 (54%) eyes at any point post-operatively. The maximum median IOP rise was +1.1 (-57.9 to +51.8) mmHg, but the degree of IOP rise correlated to the initial post-operative IOP (2 (0-18) weeks). The maximum median IOP difference in Group A was +0.1 (-57.9 to +27.2) mmHg, and in Groups B-D was +11 (-39.2 to +51.8) mmHg, p<0.0001. Medical intervention was required for 51 (6%) eyes, with 4 of these (7%) needing additional surgery. A small number have not achieved satisfactory IOP control, requiring further intervention.

Just over half (54%) of affected eyes experienced a rise in IOP from baseline at any point post-operatively, and 6% of eyes overall required medical or surgical intervention for IOP control. The IOP at the initial post-operative visit appears to be a risk factor. Larger rises in IOP from baseline were correlated to the IOP level at the initial post-operative visit, with higher risk in the IOP≥22 mmHg groups. Preliminary data shows that in the short term, the maximum IOP rise was small. In those not achieving IOP control, management is extremely challenging, with excess morbidity and lasting impact on visual outcomes.