Reported Apr 29, 2020 · Ongoing

RaySert PLUS RSP01. LOT K030. Expiry of 2024-01 - Product Usage: The single use injectors (Model STWOl and Model RSPOl)…

Rayner Intraocular Lenses Limited

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Rayner Intraocular Lenses Limited · The Ridley Innovation Centre · Worthing, N/A · N/A

Is this the product you have?

  • RaySert PLUS RSP01. LOT K030
  • Expiry of 2024-01 - Product UsageThe single use injectors (Model STWOl and Model RSPOl) are intended to be used to compress and insert into the capsular bag only those intraocular lenses that allow the use of these injectors in their approved labelling
Lot codes and dates
  • LOT K030.
Amount recalled
2425 Units.

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:31 PM UTC

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