Corneal, stent positioning reports increased after CyPass withdrawal
A negative reporting bias was identified in adverse event reports after the market withdrawal of the Alcon CyPass, according to a study presented at the virtual American Academy of Ophthalmology meeting.
“With respect to the CyPass (Alcon), our work highlights that corneal and stent position-related reports increased after their clinical significance became known,” study co-author Sarah H. Van Tassel, MD, said.
Adverse events involving CyPass devices were compiled from the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database through December 2019 and each was assigned a complication category.
“We were interested to compare complication reports before and after the CyPass market withdrawal in August 2018,” Van Tassel said.
In total, 725 reports catalogued 1,131 adverse events related to the device. Of these, 460 reports of 630 adverse events preceded market withdrawal, and 265 reports of 501 adverse events were compiled afterward.
“While overall complications reports were lower post-market withdrawal, there were selected complications ... that were significantly increased after market withdrawal,” Van Tassel said.
Reports of corneal edema rose from 12 to 26, device malposition from 54 to 106 and corneal device touch from eight to 63. Whereas there were no instances of decreased endothelial cell count without mention of corneal edema reported before market withdrawal of the device, afterward there were 70 reports.
CyPass was often performed concurrently with cataract surgery, which cannot be excluded as a cause of some reported adverse events, Van Tassel said.
Additionally, real-world complications may be underestimated in the absence of external identification such as post-market monitoring, she said.
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