Recall Z-1753-2020— Rayner Intraocular Lenses Limited

Name: FDA recall Z-1753-2020
Creator: U.S. Food and Drug Administration
Published: 2020-03-17

Class II · Ongoing

Class II FDA medical device recall by Rayner Intraocular Lenses Limited, initiated 2020-03-17. It names one FDA 510(k) clearance: K141091. 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: 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..

Recalling firm: Rayner Intraocular Lenses Limited
Classification: Class II
Status: Ongoing
Initiated: 2020-03-17
Firm location: Worthing, N/A, United Kingdom

510(k) clearances named in this recall

1 on FDA's record

K141091 — RAYSERT PLUS INJECTORRayner Intraocular Lenses , Ltd.·cleared 2014-05-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.