Healon D Lawsuit

Reports of Postoperative Eye Problems Prompts FDA Recall

FDA Issues Urgent Recall of Healon D

Opthalmic Device Linked to Serious Post Operative Eye Inflammation

The U.S. Food and Drug Administration announced a Class I recall of lot no. UD30654 of Healon D, an ophthalmic viscosurgical device (OVD) manufactured by Advanced Medical Optics Inc (AMO). OVDs are viscoelastic materials used to maintain space in the eye during surgery. Typically, OVDs are pre-packaged in a syringe and are applied using a small tube.

On Oct. 30, 2008, AMO voluntarily recalled all 4,439 units of Healon D lot no. UD30654 of Healon D, due to complaints of inflammation after eye surgery, including Toxic Anterior Segment Syndrome (TASS). At that time, AMO informed customers of the number and nature of adverse event reports associated with OVD from that lot, and included a fax reply form for quick communication.

However, as of December 3, 2008, AMO had retrieved only 964 units of the 1,450 that had been distributed in the United States.

AMO received 66 adverse event reports associated with the recalled products. Tests of this lot revealed elevated levels of endotoxin, which has been associated with post-operative intraocular inflammation and TASS.

JAN-02-09: FDA Announces Class I Recall of Ophthalmic Surgical Device [FDA: HEALON D CLASS 1 RECALL ISSUED]

Legal Help

If you or a loved one has suffered injury or illness resulting from exposure to this product, please click the link below and your complaint will be sent to a lawyer who may evaluate your claim at no cost or obligation. Related Law Suits

Healon D Law Suit and Settlement

FDA Law Suit and Settlement

CVS Law Suit and Settlement

Louisiana, USA Law Suit and Settlement

Miralus Inc. Law Suit and Settlement

Vytorin Law Suit and Settlement

Pesticides Law Suit and Settlement

Medtronic Inc. Law Suit and Settlement

Xiadafil VIP Law Suit and Settlement

Oral HRT Law Suit and Settlement

See more stories from this source.

Class Action Law Suits

Newsworthy Law Suits
Defective Products Lawsuits
Discrimination Lawsuits
Drug & Medical Claims Lawsuits
Food & Dietary Supplement Lawsuits
Insurance Lawsuits
Malpractice Lawsuits
Personal Injury Lawsuits
Real Estate Lawsuits
Investment Fraud Lawsuits

is===1 Lawyers! Become an Approved Expert to Answer Questions.

Apply Now!
You'll get lots of targetted traffic to your website and new client leads!