EXPLORATION OF IOL-BASED SAFETY EVENTS UTILIZING THE INTERNATIONAL MEDICAL DEVICES DATABASE
Published 2022 - 26th ESCRS Winter Meeting
Reference: FP64 | Type: Abstracts | DOI: 10.82333/qeej-5s82
Authors: Andrew Barton* 1 , Micheal J Gallagher 2 , Taygan Yilmaz 3
1Division of Ophthalmology,Warren Alpert Medical School of Brown University,Providence, RI,United States, 2Department of Ophthalmology,Hermitage Medical Clinic,Dubland,Ireland, 3Division of Ophthalmology,Warren Alpert Medical School of Brown Universtiy,Providence, RI,United States
Purpose
The International Medical Devices Database is a worldwide collection of reports on harmful or inadequately tested medical devices that is assembled by journalists in 36 countries. We sought to utilize this database to assess the sources of intraocular lens-based safety events.
Setting
Methods
Results
Of the 118 included safety events, 74 (61%) were recalls, while 28 (23%) were field safety notices. Most of the included safety events were related to devices from the following manufacturers: Abbott Medical Optics, Inc. (22), Carl Zeiss Meditec AG (13), Alcon Laboratories, Inc. (12), Bausch & Lomb (10), and Oculentis GmbH (9). Notably, 61 of the 118 intraocular lens-based safety events (52%) were from European manufacturers. Such safety events have been rising in frequency, with 82 events taking place between 2013 and 2018, compared to only 43 events documented between 1996 and 2012.
Conclusion
Intraocular lens-based safety events have steadily increased over the last 25 years. More investigation is necessary to determine if this rise is due to greater participation in the database, changes in consumer protection regulation, or perhaps a rise in unsafe devices in the market. Greater accountability among the common sources of recalls and field safety notices is needed in order to prevent more unsafe devices from reaching consumers.