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FDA approves Morcher capsular tension rings

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The Food and Drug Administration has approved a German manufacturer’s capsular tension rings for marketing in the United States.

Morcher GmbH received U.S. regulatory approval for its Capsular Tension Ring models 14, 14A and 14C. Capsular tension rings are designed to stabilize the capsular bag in cases of posterior capsular tear or zonular dehiscence, allowing an IOL to be implanted in the bag when it might otherwise have had to be positioned elsewhere. Morcher sought approval for its rings to be used for capsular bag stabilization in patients with pseudoexfoliation syndrome or other situations of compromised zonules, according to the proceedings of an FDA panel discussion.

In 2000, the injector used to place the ring was approved by the FDA. In 2002, the FDA’s advisory Ophthalmic Devices Panel recommended that the PMA was approvable but requested “essentially a complete reanalysis of the clinical data to resolve discrepancies in the PMA and to clarify information presented at the panel meeting,” according to the FDA’s Donna Lochner, who addressed the panel at a May meeting.

German-based Morcher has appointed FCI Ophthalmics as its U.S. distributor. For more information on the Morcher devices and other capsular tension rings, click here.