Issue: November 2016
November 21, 2016
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Ophthalmic societies advise against implantation of unregulated cosmetic iris implants

Issue: November 2016
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Several ophthalmic societies around the world have issued a warning regarding unregulated cosmetic iris implants that can cause severe ocular complications.

The American Society of Cataract and Refractive Surgery, the European Society of Cataract and Refractive Surgeons, the Asia-Pacific Association of Cataract and Refractive Surgeons and the Latin American Society of Cataract and Refractive Surgeons have put out a clinical alert advising against the implantation of any anterior chamber cosmetic iris implants that have not been studied in appropriate clinical trials, according to a press release from the ASCRS.

The color changing iris implants, which are placed into the anterior chamber of young phakic patients over a healthy iris, can cause severe and irreversible complications, including corneal decompensation, sectoral iris atrophy, glaucoma, cataract and uveitis, the release said.

Many patients require secondary surgeries, such as corneal transplantation, implantation of glaucoma tube shunts, iris repair and cataract surgery, to treat complications.

The cosmetic implants are not approved by the FDA and do not have a CE mark in Europe. There are no trials studying their safety or efficacy.