AMO Device at Heart of Warning Is No Longer Being Marketed

Abbott Medical Optics (AMO) received a warning letter citing it with failure to validate cleaning of equipment used to make Healon D ophthalmic viscoelastic devices. The company is no longer manufacturing or selling the device, Abbott spokesman Steve Chesterman said, adding that the observation does not affect other AMO products. The failure was noted in a March inspection of AMO’s Uppsala, Sweden, plant.
Devices & Diagnostics Letter