ABSTRACT NUMBER - S2009

AUSTRALIAN EXPERIENCE WITH INTRAOCULAR LENS PRODUCT FLAWS


Cherry Hong1,2, Elaine Chong2, Alex Ioannidis2, RC Andrew Symons1,2

Meeting:  2018 RANZCO


Purpose: To investigate intraocular lens (IOL) com- plications in Australia reported to the Database of Adverse Event Notification (DAEN) of the Thera- peutic Goods Administration (TGA) with an interest in lens material and manufacturing-related factors, and to evaluate the quality of such reports. Method: Global Medical Device Nomenclature (GMDN) terms for IOLs were determined from the Australian Register of Therapeutic Goods. These terms were used to query the TGA DAEN for all IOL related reports from the first report available (July 2012) until December 2017. Results were ana- lyzed using descriptive statistics. Complications were classified according to descriptions.
Results: 432 reports were harvested from the data- base: the majority of which were from 2017 (53%) and reported by the industry (95%). The most com- mon complications occurred were IOL defects/dam- age (40%), injector system problems (23%) and IOL opacification/glistenings (11%). IOL defects/damage were mostly in hydrophobic lenses (67%), and with injector use (82%). Delivery system issues were more common in preloaded (52%) than manually loaded injectors (43%). Glistenings were most fre- quent in hydrophobic lenses (71%), and opacifica- tion was mostly reported in hydrophilic acrylic lenses with hydrophobic surface (74%). Almost all reports contained missing/unclear information, with 13% missing lens model information and 9% lack- ing data concerning clinical outcome.
Conclusion: The most common IOL complications reported to the TGA were IOL defects/damage, injector issues and IOL opacification/glistenings. Associated factors of these complications were largely consistent with the published literature. There is potential for improvement of the IOL com- plication reporting system in Australia.

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