High Intraocular Pressure Spike After Eyecee One Preloaded Intraocular Lenses Implants: Aqueous Humor Analysis

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) spike in patients who underwent of EyeCee® One intraocular lenses implantation (EO-IOLs) (manufactured by Nidek, Japan and distributed by Bausch & Lomb UK Ltd).  All eye centres were instructed to stop using this IOL and to quarantine these products. To report a case-series of severe ocular hypertension (OH) secondary to uneventful EO-IOL preloaded implant in our Ophthalmic Unit and to investigate the pathogenesis of this adverse event.  

We examined 107 eyes of 107 patients who received EO-IOL preloaded IOLs between September 2022 January 2023 in our Ophthalmic Unit (San Bassiano Hospital, Bassano del Grappa, Italy)  to evaluate the rate of intraocular hypertension. Sample analysis have been performed in a technology platform center (University of Verona, Italy).

EO-IOL is a monofocal hydrophobic acrylic aspheric lens with a Blue-light filters treated with a double-polymerization manufacturing process (monomer recross-linking) to reduce the risk of glistening.. We identified 19 eyes (17.7 %) with high IOP, 5 of these, unresponsive to medical therapy, underwent glaucoma surgery. An aqueous humor (AU) sample (0.2 ml) was collected before surgery. The AH samples were processed through a dynamic light scattering (DLS) analysis.  0.2 ml of AH aspirated before routine cataract surgery from 5 normal eye, were used as a control group. With the same procedure an aqueous suspension, in which an EO-IOL had been left for 48 hours, was tested.

Three peaks (9-10 nm, 170-180 nm and 4300-4400 nm) in the pathological AH samples were founded.  2 peaks (at 9-10 and 460-470 nm) were detected in the control group.  A large peak at 133 nm and a peak at 4415 nm, which could be related to the peak that we found in the pathological sample, were founded in the solution where we had left the EO-IOL for 48 hours.  

DLS is used for measuring average nano-size particle diameter and distribution floating into the liquid. Our preliminary results analyses could demonstrate an abnormal EO-IOL release of nanoparticles in the AH that probably caused a block of the trabecular meshwork.