Raised Intraocular Pressures After Immediate Sequential Bilateral Cataract Surgery (Isbcs) With Eyecee One Preloaded Intraocular Lenses In A Large Teaching Hospital

The Medicines and Healthcare products Regulatory Agency (MHRA) issued a Device Safety Information notification on the 26 January 2023 for all eye centres to stop using and quarantine all EyeCee One and EyeCee One Crystal preloaded intraocular lenses (IOLs) immediately. This followed reports of high intraocular pressures (IOP) in approximately 2-4% of patients after recent surgery. We investigated the characteristics and management of patients who had undergone Immediate Sequential Bilateral Cataract Surgery (ISBCS) with EyeCee One lenses implanted in both eyes. This cohort was at risk of bilateral irreversible visual damage so warranted a thorough investigation to evaluate the potential harm and to identify patients at greatest risk.

The Ophthalmology department in Sheffield Teaching Hospital NHS Trust is a large tertiary referral unit that offers ISBCS for patients who meet certain criteria under local or general anesthetic (GA). Following the MHRA guidance we identified all patients who had a EyeCee One preloaded IOL as part of cataract surgery or combined procedure. These patients were contacted and reviewed to perform Duty of Candour discussion, to measure and treat any raised IOP, and to investigate any harm caused.

A search of the electronic patient record system (Medisoft LTD, Leeds UK) was performed to identify all patients who had ISBCS with EyeCee One preloaded IOL implantation between 1 October 2022 and 26 January 2023, the dates set by the MRHA guidance. Electronic and paper notes were reviewed by one clinician and data were collected including past ocular history, eye characteristics, operative details, anesthetic, and post operative examination. Patients with high IOP at a post op visit were further studied looking at whether any raised IOPs were bilateral, the medical and surgical management, response to treatment, and outcome.

58 eyes in 29 patients received ISBCS with EyeCee One IOL in both eyes. One patient had combined ISBCS and left goniosynechialysis. 8 patients (27.6%) had ISBCS under GA. 5 out of 58 eyes (8.6%) in 4 patients who had ISBCS had an IOP greater than 30mmHg at a post-op visit. 3 out of these 4 (75%) had received a GA. The average raised pressure was 44.94 (range 30.3 to 65.4) mmHg. 1 patient had bilaterally raised IOPs. All were treated with stat oral/IV acetazolamide, 3 patients received regular oral acetazolamide with an average of 2.6 topical IOP lowering drops, none required surgical intervention. Mean treated IOP’s was 17.9 (11.5-24.6) mmHg. Final median VA was 0.2 (0-0.5) LogMAR compared to the rest of the ISBCS group 0.1 (0-0.6) LogMAR.

We found 8.6% of ISBCS eyes had a post op IOP raise (>30 mmHg), a greater rate than the 2-4% initially reported by the MRHA but closer to the 6.2% found in a study of all patients who received EyeCee One IOL at our centre. There was one bilateral IOP raise in a glaucoma suspect and three unilateral cases. All cases required intensive medical treatment but responded well and did not require surgical intervention. Unexpectedly GA cases were more likely to have an IOP rise (odds ratio 4.6). We describe a unique cohort of patients with raised IOPs where they have had EyeCee One IOLs implanted in both eyes while undergoing ISBCS. The numbers are small but indicate a higher rate of post op IOP rise than previously reported.