Z-1753-2020Class II

RaySert PLUS RSP01. LOT K030. Expiry of 2024-01 -

Name: Z-1753-2020 RaySert PLUS RSP01. LOT K030. Expiry of 2024-01 -
Creator: Rayner Intraocular Lenses Limited
Published: 2020-03-17
License: https://open.fda.gov/license/

Rayner Intraocular Lenses Limited / initiated 2020-03-17 / Open, Classified / root cause: labeling and UDI

FDA source

Rayner Intraocular Lenses Limited began a recall of 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... on 2020-03-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1753-2020
Classification: Class II
Status: Open, Classified
Initiated: 2020-03-17
Posted: 2020-04-21
Recalling firm: Rayner Intraocular Lenses Limited
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.
Product code: MSS Folders And Injectors, Intraocular Lens (Iol)
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.
Root cause tag: labeling and UDI
FDA root cause: 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.
Product codes and lots: LOT K030.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1753-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1753-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-04-29	2020-04-21

Product code MSS

K141091Class IRaysert Plus InjectorRayner Intraocular Lenses , Ltd. / cleared 2014-05-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)