Abstract
Purpose :
To assess the mandatory reporting system for flaws related to intraocular lenses (IOL) and their delivery systems in Australia by evaluating cases reported to the Database of Adverse Event Notification (DAEN) of the Therapeutic Goods Administration (TGA), between July 2012 and December 2017.
Methods :
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 in the study period. Complications were classified according to reported event descriptions. Results were analyzed using descriptive statistics. For each category of complication, reports were subcategorized by IOL design, delivery system design and IOL material. Quality of reports was assessed by reference to an ideal list of data fields.
Results :
479 cases were found in the database: the majority of which were (i) from 2017 (49.5%) and (ii) reported by the industry (94.6%). The most common complications were IOL defects or damage (38.8%), injector system problems (21.7%) and IOL opacification or glistenings (10.6%). 82.3% of IOL defects or damage were associated with injector use. Delivery system issues were more common in preloaded (50.0%) than manually loaded injectors (45.2%). Glistenings were most frequent in hydrophobic lenses (73.3%), and opacification was mostly reported in hydrophilic acrylic lenses with a hydrophobic surface (72.2%). Almost all reports contained missing or unclear information, with 14.8% missing lens model information and 12.3% lacking data concerning the clinical outcome. Unfortunately, the absolute risks associated with particular lens and delivery system designs could not be determined since the absolute number of lenses and delivery systems used of each type is unavailable.
Conclusions :
The common IOL related complications reported to the TGA were IOL defects or damage, injector issues, and IOL opacification or glistenings. Factors associated with these complications were largely consistent with the published literature. The IOL related complication reporting system in Australia can potentially be improved through an IOL registry in the future.
This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.