Important Safety Alerts

Important Safety Alerts

Field Safety Notice: CLR Medicals International Inc., Visco Supreme

05 Dec 2011

It comes to our attention that The Danish Medicines Agency has received reports of post-surgical infectious endophthalmitis after using certain lots (lot no.11A03 and 11D04) of Visco Supreme manufactured by CLR Medicals International Inc.

Visco Supreme is a viscoelastic solution used during cataract surgery. Initial laboratory analysis of samples from lot 11A03 showed high bacterial load of several Bacillus spp. The Danish Medicines Agency has conducted recall of the two affected lots in Denmark.

If you are in possession of the affected product, please contact your supplier for necessary actions.

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