Public Alert No: 33/2018 – Recall Of Rain Drop Near Vision Inlay By Rvo 2.0 (D. B. A. Optics Medical)

The National Agency for Food and Drug Administration and Control has been informed of the recall of raindrop near vision inlay by RVO (Revision Optics) 2.0 (d. b. a. optics medical) due to increased risk of corneal haze (a type of cloudiness in the cornea due to inflammation).

The drug was initially designed to improve the near vision that has been lost by the eye’s natural aging process-presbyopia by surgically placing into the cornea of one eye.

The details of the recalled product are as follows;

Product: Raindrop near vision inlay,

Description: model # RD1-1

Product manufacturers: RVO (Revision Optics) Inc. 25651 Atlantic Ocean Dr Ste A1 Lake Forest CA 926308835 USA.

Recall number: Z15182017

NAFDAC implores all importers, wholesalers and retailers to immediately stop the importation, distribution and sale of raindrop near vision inlay by RVO (Revision Optics) 2.0 (d. b. a. optics medical).

Health care providers and members of the public are also advised to stop the administration and use of the affected products to avoid negative health implications. Healthcare providers and anyone in possession of the affected products should submit them to the nearest NAFDAC office.

Consumers are advised to report adverse events related to the use on any of these products to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLL FREE from all networks) or via pharmacovigilance@nafdac.gov.ng

NAFDAC………….Safeguarding the health of the Nation!!!