Allergan Recalls Ozurdex Implants over Possible Presence of Silicone Particle

Allergan is recalling several batches of its Ozurdex implant for retinal disease due to the possible presence of a silicone particle, and remaining batches that tested particle-free will be recalled once new stock is available.

Health officials in countries such as the UK, Spain, Hong Kong, and India have posted recall notices.

The US FDA has not done so, as of Oct. 19.

Market Scope called Allergan to determine if the recall applied to the US but has not received a response.

In letters to surgeons outside the US, Allergan said a routine manufacturing inspection found a silicone particle about 300 microns in diameter in some batches of Ozurdex implants (a human hair is 75 microns).

Allergan said the particle is from the needle’s silicone sleeve, and the company has identified a corrective action.

Dublin-based Allergan told regulators that most batches have a defect rate of 2 to 4 percent, but some are as high as 22 percent.

Allergan advised surgeons in the UK and Spain to consider alternative treatments in the interim and use existing Ozurdex stock only if no other treatment is suitable and the patient is advised of the possible defect and its risks.

Doctors in India were advised to stop using all existing Ozurdex stock.

The intravitreal implant contains dexamethasone 0.7 mg in the Novadur solid polymer drug delivery system.

It is indicated for macular edema due to branch or central retinal vein occlusion; non-infectious uveitis affecting the posterior segment of the eye; and diabetic macular edema.

Potential risks of silicon particle contamination include obscured vision, intraocular inflammation, and an adverse reaction in the cornea.

The company said it had not seen a trend of adverse events related to silicon particle contamination in the 1.5 million units distributed worldwide so far.

The US FDA approved Ozurdex initially in June 2009.