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Recall Observatory FDA recall evidence

Device 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.

Z-1753-2020

March 17, 2020

Class II

Product summary

Firm
Rayner Intraocular Lenses Limited
Event
Event 85270
Status
Ongoing
Classification
Class II
Quantity
2425 Units.
Official record key
device-enforcement:Z-1753-2020

Official wording

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.

Code information: LOT K030.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.