The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1338-2022·Announced 2022-07-13

Rayner RayOne Intraocular Lens Systems Mislabeled with Incorrect Lens Strength

Rayner is recalling RayOne intraocular lens injection systems because the outer package is mislabeled and contains a different lens strength than indicated. Approximately 162 devices were distributed in 13 US states.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall involving mislabeling where the outer package contains an intraocular lens with a different refractive strength than indicated on the label. No illnesses or injuries have been reported, but this represents a risk-of-harm scenario where incorrect lens strength implantation could result in patient vision problems.

Plain-English summary

Rayner Intraocular Lenses Ltd is recalling certain batches of RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems. These are preloaded injection systems containing intraocular lenses used in eye surgery.

The outer package is mislabeled and contains an intraocular lens with a different refractive strength than what the package label indicates. Batches #012183745 and #012183845, both expiring 1/17/2024, are affected.

Approximately 162 IOLs were distributed in the United States in Arizona, California, Florida, Georgia, Indiana, Michigan, Minnesota, Missouri, North Dakota, New Jersey, Oklahoma, Tennessee, and Texas. Healthcare providers in these states should verify the batch and serial numbers of any RayOne injection systems.

Patients and healthcare providers should verify the lot number and serial number of any RayOne injection systems before use. If a recalled product is identified, it should not be used. Affected individuals should contact Rayner Intraocular Lenses Ltd or the FDA for additional information.

The recalled product

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…
Manufacturer
Rayner Intraocular Lenses Ltd
Category
Medical Device — Ophthalmic / Intraocular Lens
Hazard
Affected units
162

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (13)

  • 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
  • all serial numbers
  • UDI (01)05029867006722.

Distribution

Distributed nationwide across the United States.

The notice also names 13 states specifically:

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