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Open, Classified

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.

FDA Recall Z-1753-2020 · Posted None

Recalling FirmRayner Intraocular Lenses Limited
Recall StatusOpen, Classified
Product CodeMSS
Date Initiated2020-03-17
Product Quantity2425 Units.

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.

Firm 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.

Root Cause

Labeling mix-ups

Distribution Pattern

US nationwide distribution in the states of OH, FL, GA, MD, SC, NJ, PR, IN, ID and MN.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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