FDA recall Z-1753-2020

Rayner Intraocular Lenses Limited · Class II · device

Product

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

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

Key facts

Status
Ongoing
Initiation date
2020-03-17
Report date
2020-04-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Worthing, N/A, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1753-2020