THE Food and Drug Administration (FDA) calls for product recall of all Lentis Intraocular Lens (IOL) distributed and imported by Ophthaswissmed Philippines, Inc. with expiration dates between January 2017 to May 2020.
According to the official statement released by FDA, Oculentis BV, the manufacturer of the said item “received notifications of sporadic late postoperative opacification of Lentil IOLs.” This, in the long run, may compromise the optical transparency of IOLs which may lead to a “slow reduction in the patient’s visual acuity.”
Included IOLs products are the Lentis (MDR-04652), Lentis Comfort (MDR-04654), Lentis T Plus (MDR-04647), Lentis T Plus X (MDR-04707), Lentis Comfort Toric (MD-04708), Lentis M Plus (MDR-04651), Lentis M Plus X (MDR-04653), Lentis M Plus Toric (MDR-04719), and the Lentis M Plus X Toric (MDR- 04706).
Studies made by Oculentis BV suggests that the opacification may have been led by the phosphate remnants present in the cleaning agent used in production. They assured that currently produced and those IOLs with expiry dates of June 2020 and later are unaffected and can be used safely and effectively.
FDA advised healthcare professionals and establishment to discontinue use, sale, and distribution of the affected product.