Texas man claims recalled device caused eye problems

Michelle Massey, East Texas Bureau Dec. 7, 2009, 7:15am

MARSHALL � A Tyler resident alleges a defective medical device recalled just two days after his cataract surgery caused unnecessary eye inflammation.

Wayne Bishop filed a product liability lawsuit against Advanced Medical Optics Inc., the manufacturer of the Healon D Ophthalmic Viscosurgical Device, on Dec. 4 in the Marshall Division of the Eastern District of Texas.

The device was used to aid in iris retraction while the plaintiff underwent a cataract extraction with intraocular lens implant on his right eye in October 2008.

Bishop states he was sent to a retina specialist due to the swelling and was told a cornea transplant would be needed if the problem did not resolve on its own. Five months later and with the swelling unresolved, Bishop underwent a corneal transplant and a new graft.

The medical device was subject to a Class I recall two days after the plaintiff's surgery in October 2008 due to complaints of inflammation after eye surgery, including Toxic Anterior Segment Syndrome.

According to the complaint, the recall was due to "unsafe and high endotoxin levels within the Healon D which could cause intraocular inflammation and/or TASS in patients following surgery."

The plaintiff alleges that the device manufacturer is negligent for failing to adequately test and inspect the safety of the product.

In addition, Bishop claims Advanced Medical Optics is negligent for failing to utilize and implement a reasonably safe design practice to avoid unsafe levels of endotoxins and for failing to timely warn physicians after discovering the potential safety hazard and risks associated with Healon D.

"Safer alternative designs were available that did not involve the use of toxins potentially dangerous to patients and which would be safe, effective and financially viable," the complaint argues.

Bishop also alleges that the device was defectively designed, manufactured and marketed.

Bishop is seeking damages for medical and pharmaceutical expenses, loss of earning capacity, physical pain and suffering, mental anguish, disfigurement and physical impairment.

Tyler attorney Jeffrey T. Embry of the law firm Hossley and Embry LLP is representing the plaintiff.

Jury trial requested.

U.S. District Judge T. John Ward is presiding over the litigation and has referred the case to Magistrate Judge Charles Everingham for pretrial proceedings.

Case No 2:09cv00376

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