Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported April 29, 2020
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.
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 numb…
Rayner Intraocular Lenses Limited recalled RaySert PLUS RSP01. LOT K030. Expiry of 2024-01 - Product Usage: The single use injectors… - a moderate-severity action.
RaySert PLUS RSP01. LOT K030. Expiry of 2024-01 - Product Usage: The single use injectors… was recalled by Rayner Intraocular Lenses Limited in April 29, 2020. Reason: RaySert PLUS RSP01 LOT K030 labeled with an expiry of 2024-01 contained an inner tray that was labeled with a…. Check the official notice for the remedy. Verify recall #Z-1753-2020 with the FDA Devices before acting.
The recall
Rayner Intraocular Lenses Limited issued this moderate-severity FDA Devices recall-RaySert PLUS RSP01 LOT K030 labeled with an expiry of 2024-01 contained an inner tray that was labeled with a….
- Moderate
- severity level
- 2K units
- affected scope
- Class II
- classification
- April 29, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1753-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
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 list the affected scope as 2425 Units..
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.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
2425 Units.
Related Recalls
6
3 from same agency
Product description
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1753-2020 |
| Date reported | April 29, 2020 |
| Date initiated | March 17, 2020 |
| Recalling firm | Rayner Intraocular Lenses Limited |
| Firm location | Worthing, N/A |
| Affected scope | 2425 Units. |
| Distribution | US nationwide distribution in the states of OH, FL, GA, MD, SC, NJ, PR, IN, ID and MN. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1753-2020) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Rayner Intraocular Lenses Limited. Units affected: 2425 Units..
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 29, 2020. Severity: Moderate. Recall number: Z-1753-2020.
Where was the recalled product distributed? ▼
Distribution: US nationwide distribution in the states of OH, FL, GA, MD, SC, NJ, PR, IN, ID and MN..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1753-2020) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 29, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.