October 24, 2019
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Allergan recalls certain lots of Xen 45
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Allergan is voluntarily recalling certain lots of the Xen 45 glaucoma drainage device after a small number of units in an unreleased lot of the product were observed to have trace amounts of polishing compounds, according to a news release posted on the American Society of Cataract and Refractive Surgery website.
The polishing compounds are used in the needle sleeve manufacturing process.
Furthermore, Allergan has issued a “product hold” on the device as a safety precaution while the company investigates the issue.
Allergan had no further comment on the recall to Healio/OSN.
The company advises physicians to continue routine postoperative follow-up and report any adverse events to its product surveillance at 1-800-433-8871.