TY - JOUR AU - Andrés Iglesias, Cristina AU - Fernández Bueno, Iván AU - Pastor Idoate, Salvador AU - Coco Martín, Rosa María AU - Pastor Jimeno, José Carlos PY - 2024 SN - 1663-9812 UR - https://uvadoc.uva.es/handle/10324/68992 AB - Abstract Introduction: Ala®sil infusion was on the market for clinical use under the Medical Devices Directive (MDD) 93/42/EEC as an irrigating solution based on polydimethylsiloxane (PDMS). The product was withdrawn in 2016, and to the best of our... LA - eng PB - Frontiers Media SA KW - Ophthalmic medical devices KW - Low-molecular-weight components, KW - Toxicity KW - Silicone oil KW - Q12 KW - Polydimethylsiloxane KW - MDR TI - Ala®sil chemical characterization and toxicity evaluation: an example of the need for the Medical Device Regulation 2017/745 DO - 10.3389/fphar.2023.1310463 ER -