The Recall Desk

Manufacturer

Rayner Intraocular Lenses Ltd

1 recall in our database name Rayner Intraocular Lenses Ltd as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2022-07-13

Of the 1 recalls from Rayner Intraocular Lenses Ltd we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–1 of 1

  • HighFDA (Devices)·Z-1338-2022·2022-07-13

    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.

    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 EM
    Category
    Medical Device
    Distribution
    Distributed nationwide