FDA Medical Device Recalls (openFDA)
Rayner Intraocular Lenses Limited: 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.
- Recall number
- Z-1753-2020
- 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.
- Status
- Open, Classified
- Initiated
- 2020-03-17
- Posted
- not on file
- Terminated
- not on file
- 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.
- 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
- 2425 Units.
- Distribution
- US nationwide distribution in the states of OH, FL, GA, MD, SC, NJ, PR, IN, ID and MN.
- Lot, serial or model codes
- LOT K030.
- 510(k) numbers
- ["K141091"]
- PMA numbers
- not on file
- Product code
- MSS
- Firm FEI
- 3012304651
- Firm city
- Worthing
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28