Ministry of Food and Drug Safety Recalls 16 Types of Soft Contact Lenses: "Change Not Certified"

Davichi Lens 3 Day Color Among Recalled Products
"No Safety Concerns for Consumers," Says Ministry

The Ministry of Food and Drug Safety announced on February 1 that it has ordered the recall of 16 models of daily-wear soft contact lenses, including the "Davichi Lens 3 Day Color," manufactured by the medical device company DK Medi Vision.

Davichi Lens 1 Month Color New Miracle Choco. Provided by the Ministry of Food and Drug Safety

The products subject to recall include the following from the Davichi Lens 3 Day Color line: Treview New Miracle Brown, Treview New Miracle Choco, New Starry Day Brown, New Starry Night Black, Dolche Ring Gray, Dolche Ring Brown, and Selene Brown. Also included are the following from the Davichi Lens 1 Month Color line: New Miracle Brown, New Miracle Choco, Pure Ring Gray, and Pure Ring Olive.

The recall also covers the following from the Davichi Lens 1 Day Color line: Pure Ring Brown 1 Day and Pure Ring Choco 1 Day, as well as from The Lens: 1 The Lens Grace Brown, 1 The Lens Grace Khaki, and 1 The Lens Grace Gray.

The Ministry of Food and Drug Safety found during an inspection that the company had outsourced the production and sale of certain products to external manufacturers, even though these daily-wear soft contact lenses had already received medical device certification. The ministry determined that this practice constituted a failure to obtain the required change certification under the Medical Device Act and plans to take administrative action.

According to Articles 12 and 13 of the Medical Device Act, medical device manufacturers must obtain change certification if there are any changes to certified items such as the manufacturer.

However, the Ministry of Food and Drug Safety assessed that there are no safety concerns, considering that the affected products are already certified daily-wear soft contact lenses, the subcontracted manufacturers are also daily-wear soft contact lens producers, and only products that passed in-house quality inspections were shipped.