Berlin-based Oculentis has issued a voluntary recall in the Philippines for all Lentis intraocular lenses distributed and imported by Ophthaswissmed Philippines, Inc., with an expiration date of January 2017 to May 2020. The Philippines Food and Drug Administration (FDA) issued an advisory Oct. 27.
The agency said Oculentis has received notifications of sporadic late postoperative opacification of the lenses, which may compromise the transparency of the lens over time, potentially leading to reduced visual acuity.
The Philippines FDA said studies by Oculentis indicate that the opacification may be caused by phosphate remnants from a cleaning agent used in production.
The recall covers the Lentis (MDR-04652), Lentis Comfort (MDR-04654), Lentis T Plus (MDR-04647), Lentis T Plus X (MDR-04707), Lentis Comfort Toric (MDR-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).
Oculentis says Lentis IOLs with an expiration of June 2020 or later are unaffected.
The recall notice did not specify whether lenses in other countries are affected or other regulatory bodies have been notified. Oculentis did not respond to a request for additional information.