Safety Notice

Dear Doctors,

A Field Safety Notice (VAIM-FSCA-03) issued by VAIM Co. Ltd. has recently been published on the website of the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL), concerning a restriction on injecting the medical device Juvelook in the eye area. We understand this may have caused concern, but there is no change in the approved use of Juvelook.

Following the report of a single adverse event in one patient, URPL noted imprecise wording in the Instructions for Use (IFU), which currently mentions the entire eye area, including the upper eyelid.

VAIM Global, the manufacturer of Juvelook, is now in the process of updating the IFU. In line with URPL’s recommendations, the revised instructions will provide a clearer description of the injection zones, with a precise indication of safe and contraindicated areas.

Please note that in the protocols distributed by Beautyeurope.eu, the application guidelines for Juvelook are correct and compliant with current regulations. However, URPL has requested the manufacturer to refine the IFU.

The updated leaflet will explicitly state that Juvelook must not be used in the following eye areas:

• eyebrows
• ocular space
• eyelashes
• upper eyelid
• tear duct

It will also include instructions that the product should not be injected too superficially, and that massaging the treated area after injection can help reduce the risk of nodules or lumps by ensuring even distribution.

If you have any questions, please contact your representative or reach out to us at: biuro@beautyeurope.eu