FDA-Device2020-04-29Class II
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.
Rayner Intraocular Lenses Limited
Hazard
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.
Sold states
US nationwide distribution in the states of OH, FL, GA, MD, SC, NJ, PR, IN, ID and MN.
Affected count
2425 Units.
Manufactured in
The Ridley Innovation Centre, 10 Dominion Way, Worthing, N/A, United Kingdom
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1753-2020Don't want to check this manually?
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