Rayner RaySert PLUS Intraocular Lens Injector Recall for Labeling Error
Rayner Intraocular Lenses Limited is recalling RaySert PLUS RSP01 injectors due to a mismatch between the outer and inner tray expiration dates and lot numbers.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is a labeling error (mismatched lot and expiry dates) rather than a direct contamination or structural defect, and no injuries have been reported.
Plain-English summary
Rayner Intraocular Lenses Limited is recalling 2,425 units of RaySert PLUS RSP01 single-use intraocular lens injectors. The affected units are identified by Lot K030 and have an outer expiration date of January 2024.
The recall was initiated because the inner tray of these injectors was labeled with an expiration date of 2015 and a different lot number, V001. This discrepancy between the outer packaging and the inner tray labeling creates a potential for confusion regarding the product's identity and shelf life.
The affected injectors were distributed nationwide in the United States, specifically in the states of Ohio, Florida, Georgia, Maryland, South Carolina, New Jersey, Puerto Rico, Indiana, Idaho, and Minnesota. These devices are intended to be used by healthcare professionals to compress and insert specific intraocular lenses into the capsular bag during surgery.
Healthcare facilities and distributors should stop using the affected units and contact Rayner Intraocular Lenses Limited for instructions on how to return the product. No injuries or illnesses have been reported in connection with this recall.
The recalled product
- 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…
- Manufacturer
- Rayner Intraocular Lenses Limited
- Hazard
- Affected units
- 2,425
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- LOT K030.
Distribution
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