RegWardenFDA facility compliance records
Company

Rayner Intraocular Lenses Limited

3 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2018: 1 recalls; 2020: 1 recalls; 2022: 1 recalls2017120182019120202021120222023202420252026
  • Recalls (3)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2022-05-13
    The outer package is mislabeled and the package contains a different IOL strength.
  • Class IIOngoing2020-03-17
    RaySert PLUS RSP01 LOT K030 labeled with an expiry of 2024-01 contained an inner tray that was labeled with an expiry of 2015. In addition to having an expiry of 2015 the LOT number on the inner tray is identified as V001.
  • Class IITerminated2018-08-09
    Firm become aware of reports of post-operative refractive errors following implantation of lenses.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Rayner Intraocular Lenses Limited — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-8010143-rayner-intraocular-lenses-limited/

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