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 Insight

This FDA Devices action (record #Z-1753-2020) was formally reported on April 29, 2020, with the manufacturer initiating the action on March 17, 2020. It is classified under Moderate severity (Class II), with a current status of Ongoing. Rayner Intraocular Lenses Limited is listed as the recalling firm, operating out of Worthing, N/A. Federal records indicate 2425 Units. units are affected.

The documented reason for this recall is: 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 V0… Distribution data in the federal record shows the product reached: US nationwide distribution in the states of OH, FL, GA, MD, SC, NJ, PR, IN, ID and MN.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 6 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.