The Danish Medicines Agency has received 44 reports on cases of infection of the interior of the eye (endophthalmitis) following treatment with Visco Supreme (batch nos.11A03 and 11D04) from CLR Medicals International Inc. A total of 93 treatments were made with the products in question.
On the basis of these events, the Agency has prohibited marketing of Visco Supreme, and the affected products have been recalled.
The Agency would like to emphasise that patients who have undergone treatment with the products in question are eligible for claiming compensation via the Danish Patient Insurance Association.
For further information, see the Danish Patient Insurance Association's website (in Danish only). Infections following use of the product Visco Supreme and Make a claim.
The Agency has also informed all involved doctors about the possibility of claiming compensation.
