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

Recall date

March 17, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1753-2020

FDA classification

Class II

Brand / firm

Rayner Intraocular Lenses Limited

Sold / distributed

US nationwide distribution in the states of OH, FL, GA, MD, SC, NJ, PR, IN, ID and MN.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

RaySert PLUS RSP01. LOT K030. Expiry of 2024-01 - Product Usage: The 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.