Home / Recalls / Rayner Intraocular Lenses Limited / Z-1753-2020

Z-1753-2020 Class II Ongoing

Recalled by Rayner Intraocular Lenses Limited — Worthing, N/A

Recall Details

Product Type: Devices
Report Date: April 29, 2020
Initiation Date: March 17, 2020
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2425 Units.

Product Description

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.

Reason for Recall

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.

Distribution Pattern

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

Code Information

LOT K030.