Rayner Recalls RayOne Preloaded Hydrophilic IOLs Due to Package Mislabelling

According to a notice published by the FDA on July 6, Rayner has issued a letter to recall its RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems containing one MICS injection system with Intraocular Lens. The reason behind this was that the outer package is mislabeled and the package contains a different IOL strength.

Mislabelling Details of the Affected IOLs

Accordingly, the outer carton labeled as Rayner RayOne EMV US, REF RAO200E, SE: +19.00D, Sph: +19.00D, while the inner primary device packaging labeled as Rayner RayOne EMV US, REF RAO200E, SE: +21.00D, Sph: +21.00D.

Actions Taken by Rayner to Address the Issue

On May 12, Rayner sent two to the importer warehouse, instructing them to freeze all units of the affected lots from further distribution, provide the number of units in inventory, and provide the accounts that have been sent the units so they can track them.

Additionally, the sales team was requested to return the affected batch to a designated warehouse and send a response form to the customers that are affected by the product. The response form was to be completed with the lot number of the IOL, whether it was implanted, the date implanted, was there a refractive error, whether it is being returned, and the date of return.

The notice said that 162 IOLs are affected and the recalling process still continues because not all products have been corrected or removed yet. Meanwhile, the company said that they would cover all return costs and replace the affected stock.