Recall Z-1753-2020 ยท MSS Folders And Injectors, Intraocular Lens (Iol)
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.
| Date | Mar 17, 2020 |
| Status | Open, Classified |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141091 | RAYSERT PLUS INJECTOR Rayner Intraocular Lenses , Ltd., May 28, 2014 |