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Evaluation of raised intraocular pressure post EyeCee One preloaded intraocular lenses implantation

Eye volume 37, pages 3293–3294 (2023)Cite this article

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Medicine and Healthcare products Regulatory Agency (MHRA) issued a Device Safety Information (DSI) notification (DSI/2023/001) on 26 January 2023 regarding reported cases of increased intraocular pressure (IOP) in patients who received implantation of EyeCee One preloaded intraocular lenses (IOLs) (manufactured by Nidek, Japan and distributed by Bausch & Lomb UK Ltd) and instructed all eye centres in the UK to stop using and to quarantine these products [1]. Reportedly, a rate of 2–4% of high IOP (value unspecified) was found in some patients, who apparently experienced minimal symptoms [2].

A large public teaching hospital ophthalmology department in the UK (Sheffield Teaching Hospital NHS Trust) has strictly followed the actions given by MHRA and commenced thorough investigations for all the patients who received EyeCee One preloaded IOLs between 1October 2022 (date required by MHRA to recall patients from) and 26 January 2023 (date of the MHRA DSI/2023/001) to evaluate the serious concern and potential harm caused to patients as a result. An electronic medical record search (Medisoft Ltd, Leeds, UK) identified EyeCee One preloaded IOLs implantation in 820 eyes of 758 patients. 51 eyes (6.2%) were identified to have an IOP of equal and above 30 mmHg at their first post-operative visit. This included 14 eyes with either glaucoma (open or closed angle) or ocular hypertension (OHT) prior to cataract surgery and 5 eyes receiving combined pars plana vitrectomy (PPV) and phacoemulsification using EyeCee One IOLs (Table 1). Raised IOP is not uncommon post-operatively in PPV and gas tamponade cases and our vitreoretinal cohort showed that the IOP spike settled in all 5 eyes with medical management. In the glaucoma and OHT cohort, five patients had pre-operative IOP of above 22 mmHg and one patient had combined phacoemulsification with goniectomy TrabEx + (MicroSurgical Technology, Redmond, USA), which resulted in post-operative hyphema with an IOP spike of 36.1 mmHg. To date (10 February 2023 with post-operative follow up duration of mean 6.1 ± 4.1 weeks), the vast majority of increased IOP cases (92.2%) were managed medically with either topical, systemic IOP-lowering medications or both. However, three eyes required additional surgical interventions to manage persistent IOP spikes, including one eye requiring an IOL exchange combined with PPV after MHRA DSI/2023/001 was issued. One further eye required ‘wound burping’ at slit lamp. All the four cases remain under close observation in our unit.

Table 1 Pre-, intra- and post-operative characteristics of patients who received EyeCee One preloaded intraocular lenses (IOLs) with post-operative intraocular pressure (IOP) spike of ≥30 mmHg.
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Authors and Affiliations

  1. Ophthalmology Department, Sheffield Teaching Hospital NHS Trust, Sheffield, UK

    Haoyu Wang, Stephanie J. Chiu, William L. Kay & Jennifer H. Y. Tan

  2. Academic Unit of Medical Education, University of Sheffield, Sheffield, UK

    Haoyu Wang, Joel L. Z. Jong, Stephanie J. Chiu & Jennifer H. Y. Tan

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  1. Haoyu Wang
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  2. Joel L. Z. Jong
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Contributions

Concept and Design of the work: HW and JHT. Acquisition, analysis or interpretation of data: HW, JLJ, SJC, WLK, and JHT. Drafting the manuscript or revising it critically: HW, SJC, and JHT. Final approval of the version to be published: HW, JLJ, SJC, WLK, and JHT.

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Correspondence to Haoyu Wang or Jennifer H. Y. Tan.

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Wang, H., Jong, J.L.Z., Chiu, S.J. et al. Evaluation of raised intraocular pressure post EyeCee One preloaded intraocular lenses implantation. Eye 37, 3293–3294 (2023). https://doi.org/10.1038/s41433-023-02487-y

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