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U.S. Department of Health and Human Services

Class 2 Device Recall RaySert PLUS

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  Class 2 Device Recall RaySert PLUS see related information
Date Initiated by Firm March 17, 2020
Create Date April 21, 2020
Recall Status1 Open3, Classified
Recall Number Z-1753-2020
Recall Event ID 85270
510(K)Number K141091  
Product Classification Folders and injectors, intraocular lens (iol) - Product Code MSS
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.
Code Information LOT K030.
Recalling Firm/
Manufacturer		 Rayner Intraocular Lenses Limited
The Ridley Innovation Centre
10 Dominion Way
Worthing United Kingdom
For Additional Information Contact Jodie Neal
01-903-258693
Manufacturer 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.
FDA Determined
Cause 2		 Labeling mix-ups
Action Rayner lntraocular notified customers on 03/17/2020 via "Urgent Medical Device recall" letter. The recall letter identified the affected product and lot number. The customers were asked to immediately quarantine and return the product.
Quantity in Commerce 2425 Units.
Distribution US nationwide distribution in the states of OH, FL, GA, MD, SC, NJ, PR, IN, ID and MN.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MSS and Original Applicant = RAYNER INTRAOCULAR LENSES LTD.
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