FDA Advisory No. 2017-288
Voluntary Product Recall of All Lentis Intraocular Lens with expiry date between 2017-01 and 2020-05
All concerned healthcare professionals and establishments are hereby advised by the Food and Drug Administration (FDA) regarding the voluntary product recall of all Lentis Intraocular Lens (IOL) having an expiry date between 2017-01 and 2020-05 (see photos of the product below) distributed and imported by Ophthaswissmed Philippines Inc.
Ophthaswissmed received a notice of product recall from the Oculentis BV, the manufacturer of the above-mentioned medical device product. Oculentis received notifications of sporadic late postoperative opacification of Lentis IOL’s. Opacification may compromise the optical transparency of the IOL’s in time, potentially leading to a slow reduction in the patient’s visual acuity. Studies made by the manufacturer have indicated that opacification could possibly be the result of phosphate remnants from a phosphate-containing cleaning agent used in the production. Oculentis assured that all currently produced and all Lentis IOL’s products on the market with an expiry date of 2020-06 or later are completely unaffected and may be used safely and effectively.
All concerned healthcare professionals and establishments are advised to discontinue further use, sale and distribution of the said affected medical device product.
Dissemination of the information to all concerned is requested.