Acute retinal toxic damage by AlaOcta® a liquid perfluorooctane liquid used in retinal detachment surgery. Clinical picture and functional consequences

Abstract

Purpose : In a series of patients with non-complicated retinal detachments, AlaOcta® a liquid perfluoro-octane was used. Due to the inability of current ISO 10993 protocols to detect some potential impurities in sanitary products, this surgical tool caused severe cases of retinal acute toxicity. The purpose of this work is to describe the clinical picture and functional consequences.

Methods : We analyzed the cases reported by 28 Spanish Ophthalmology Centers to the National Agency for Medicine and Sanitary Products. A panel of 6 expert retinologists analyzed all available information from patients charts and clinical retinal images (retinographies and OCT). In some cases additional information could be obtained.

Results : 117 cases were notified, and 96 were clearly related to the intraoperative use of AlaOcta®. Initial picture, in the most severe cases, was acute retinal necrosis (n= 38) and vascular (vein and artery) occlusion (n= 33) in the 24 h of post-operative period followed by retinal atrophy (n= 46) (OCT demonstrated), optic nerve atrophy (n= 82), macular holes formation (n= 16) and proliferative vitreoretinopathy (PVR) development (n= 13). After 3 months of follow up, 53 eyes had no light perception and 97 eyes were below measurable visual acuity.

Conclusions : Although AlaOcta® was checked for cytotoxicity by a certified and specialized German company, protocols and methodology accepted by the European Union (ISO protocols) failed at detecting the presence of highly toxic compounds. These current protocols for intraocular sanitary products should be revised.

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.