Z-1338-2022Class II

RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems containing one MICS injection system with...

Name: Z-1338-2022 RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems containing one MICS injection system with...
Creator: Rayner Intraocular Lenses Ltd
Published: 2022-05-13
License: https://open.fda.gov/license/

Rayner Intraocular Lenses Limited / initiated 2022-05-13 / Open, Classified / root cause: labeling and UDI

FDA source

Rayner Intraocular Lenses Ltd began a recall of RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems containing one MICS injection system with Intraocular Lens: (1) Outer carton labeled as Rayner... on 2022-05-13. FDA classified it as Class II and gives the reason as "The outer package is mislabeled and the package contains a different IOL strength". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1338-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-05-13
Posted: 2022-07-06
Recalling firm: Rayner Intraocular Lenses Limited
Product: 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.
Product code: HQL Intraocular Lens
Reason for recall: The outer package is mislabeled and the package contains a different IOL strength.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: 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
Quantity in commerce: 162 IOLs
Distribution: US Nationwide distribution in the states of AZ, CA, FL, GA, IN, MI, MN, MO, ND, NJ, OK, TN, and TX.
Product codes and lots: Outer carton +19.0 D - Batch #012183745, exp. 1/17/2024, Serial numbers 01-06, 10, 21, 24-45, 48-53, 58-60, 61-65, and 68-81, UDI (01)05029867006685. Outer carton +21.0 D - Batch #012183845, exp. 1/17/2024, all serial numbers, UDI (01)05029867006722.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1338-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1338-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-13	2022-07-06

Product code HQL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)