RayOne EMV recallZ-1338-2022 · Rayner Intraocular Lenses Ltd · initiated May 13, 2022

Why it was recalled

The outer package is mislabeled and the package contains a different IOL strength.

FDA root cause category: Under Investigation by firm

What the company is doing

The recalling firm sent two emails to the importer warehouse on 5/12/2022 instructing them to freeze all units of the affected lots from further distribution, provide the number of units in inventory, and to provide the accounts who have been sent the units so they can track them. On 5/13/2022, the recalling firm sent an email to their sales team requesting all unused units from the affected batch be returned to a designated warehouse (the importer, which was listed as a direct account). The email included an attached letter and a response form that the sales team was to send to any of their accounts who are affected. The email noted that Rayner would cover all return costs and replace the affected stock. The attached customer letter was dated 5/13/2022 requesting return of all unused units of the affected batch to the address listed in the letter. The letter noted that an official letter will follow subject to FDA approval, however, in the interim, the customer was requested to complete and returned the attached response form. 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 facility is to indicate they have read and understood the contents of the letter and that all affected persons have been notified of the field action. A second letter was issued to the customers dated 5/24/2022 via email on the same date. The customer was requested to complete and return the attached response form at their earliest convenience if not already done. The email also asked for additional information be provided if the IOL has been implanted, such as (1) confirm the patient's post-operative outcome; (2) if applicable, confirm the degree of the refractive error; (3) does the refractive error require correction; and (4) if the refractive error requires correction, is surgical exchange expected. The attached letter expla

Recall details

Recall number

Z-1338-2022

Status

Open, Classified

Initiated by the company

May 13, 2022

Recalling firm

Rayner Intraocular Lenses Ltd

Quantity

162 IOLs

Product code

HQL

FDA submissions

P060011S025

Distribution

US Nationwide distribution in the states of AZ, CA, FL, GA, IN, MI, MN, MO, ND, NJ, OK, TN, and TX.

Product description

RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems containing one MICS injection system with Intraocular Lens: (1) Outer carton labeled as Rayner RayOne EMV US, REF RAO200E, SE: +19.00D, Sph: +19.00D; and (2) Inner primary device packaging labeled as Rayner RayOne EMV US, REF RAO200E, SE: +21.00D, Sph: +21.00D.

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

• RayOne EMV RAO200E

  Rayner Intraocular Lenses Limited · Intraocular Lens
  1 recall15 reports
• RayOne EMV RAO200E

  Rayner Intraocular Lenses Limited · Intraocular Lens
  1 recall2 reports

Product lines

• RayOne EMVRayner Intraocular Lenses Limited · 16 models · 43 reports · 1 recall