AMO: limited recall of Healon D

Article

Following limited reports of adverse events encountered by US physicians using a particular batch of Healon D viscoelastic, AMO has recalled the remaining products in the batch.

Following limited reports of adverse events encountered by US physicians using a particular batch of Healon D viscoelastic, AMO has recalled the remaining products in the batch.

AMO has already notified customers who are in possession of Healon D from the batch in question. The rest of the lot has been removed from AMO's inventory, and AMO is planning to notify the FDA.

According to the manufacturers, the adverse events - ocular inflammation at one day postoperatively - are restricted to a single batch of Healon D. No such reactions have been reported in Europe, and no other AMO viscoelastic products have been affected.

Related Videos
A screenshot of Dr Filomena Ribeiro, president of the ESCRS
Ramin Tadayoni, MD, speaks with Sheryl Stevenson
Jennifer I. Lim, MD, FARVO, FASRS, Director of Retina Service, University of Illinois at Chicago
Anat Loewenstein, MD, Professor and Director, Department of Ophthalmology, Tel Aviv Medical Center
Carl D. Regillo, MD, FACS, FASRS, Chief of Retina Service, Wills Eye Hospital, Philadelphia, PA
Arshad Khanani, MD, MA FASRS, on a virtual call
Penny A Asbell, MD, FACS speaks at the 2023 AAO meeting
© 2024 MJH Life Sciences

All rights reserved.