AMO Issues Recall for Eye Surgery Syringes

Advanced Medical Optics (AMO) has issued a recall of its Healon D Ophthalmic Viscosurgical Device (OVD) due to contamination issues.

The Food and Drug Administration (FDA) announced that many ophthalmologists using the product noticed an inflammation in their patients immediately following eye surgery. The syringes have been used in conjunction with cataract surgery, corneal transplant surgery, and glaucoma filtration surgery.

The FDA commenced the recall when clinical tests determined that the device contained endotoxin levels that were overly high, increasing patient risk of Toxic Anterior Segment Syndrome (TASS). If not treated promptly, this condition will cause permanent eye damage.

This is a Class I recall, which means that the product is very likely to cause serious injury or death.

AMO has previously issued a recall for another of their eye care products, Complete MoisturePlus contact lens solution. This recall was also due to contamination issues with the product. Their Complete MoisturePlus contact lens solution led to severe eye infections and permanent eye damage in victims.