Anterior chamber lenses. Part II: A laboratory study.
An analysis of 606 surgically removed anterior chamber intraocular lens (IOL) specimens revealed that 351 or 58% of these were small-diameter, round loop, closed-loop styles. Because of the extremely high percentage of IOLs with this design received in our laboratory and the correlation of clinical histories with our histopathologic findings, we have concluded that such IOLs do not provide the safety and efficacy achieved by other anterior chamber lens designs. The finely polished, one-piece, all-PMMA styles fared well in our study. Although these one-piece styles comprise well over 50% of the American market share of anterior chamber IOLs, they comprise only 14% of all anterior chamber IOLs accessioned in our laboratory, compared to 58% for closed-loop designs. We believe that implantation of anterior chamber lenses with small-diameter, round, closed loops is no longer warranted. Patients in whom these IOLs have already been implanted should be carefully followed. It is our opinion that the FDA should recall or closely monitor all IOLs of this design and that implantation of closed-loop lenses should be discontinued in the United States. Furthermore, we believe that an IOL deemed to be not medically sound or worthy of implantation in the United States should not be marketed or donated outside of this country.
D000867:Anterior Chamber; D005069:Evaluation Studies as Topic; D006801:Humans; D007910:Lenses, Intraocular / Q000009:adverse effects*; D011474:Prosthesis Design