Recall of intraocular lenses “Ioflex Foldable Intraocular lenses”, Mediphacos Ltda (Belo Horizonte, Brazil)
2013.01.28
Product group Non-active implants - special implants
Reference 02014/11
Mediphacos Ltda (Belo Horizonte, Brazil) is conducting a recall of intraocular lenses “Ioflex Foldable Intraocular lenses”. The recall is based on the presence of silicone residues in the packaging components which can prone to the calcification of the IOL after implantation.
Mediphacos Ltda has issued an updated Field Safety Notice amending the list of affected intraocular lenses.