Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported February 26, 2014
Bausch & Lomb AKREOS AO Micro Incision Lens The Akreos IOL intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients.
Lens was manufactured with incorrect raw material.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Bausch & Lomb Surgical, Inc. recalled Bausch & Lomb AKREOS AO Micro Incision Lens The Akreos IOL intended for primary impla… - a moderate-severity action.
Bausch & Lomb AKREOS AO Micro Incision Lens The Akreos IOL intended for primary impla… was recalled by Bausch & Lomb Surgical, Inc. in February 26, 2014. Reason: Lens was manufactured with incorrect raw material.. Check the official notice for the remedy. Verify recall #Z-1062-2014 with the FDA Devices before acting.
The recall
Bausch & Lomb Surgical, Inc. issued this moderate-severity FDA Devices recall-Lens was manufactured with incorrect raw material..
- Moderate
- severity level
- Class II
- classification
- February 26, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1062-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1062-2014) was formally reported on February 26, 2014, with the manufacturer initiating the action on October 16, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Bausch & Lomb Surgical, Inc. is listed as the recalling firm, operating out of Clearwater, FL. Federal records list the affected scope as 336 IOLs (283 IOLs in the US, 53 IOLs outside the US).
The documented reason for this recall is: Lens was manufactured with incorrect raw material. Distribution data in the federal record shows the product reached: Worldwide Distribution: US (nationwide) and Internationally to: Great Britain, France, Spain, Portugal, Sweden, Russia and Guadeloupe.. 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
336 IOLs (283 IOLs in the US, 53 IOLs outside the US)
Related Recalls
6
3 from same agency
Product description
Bausch & Lomb AKREOS AO Micro Incision Lens The Akreos IOL intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients.
Reason for recall
Lens was manufactured with incorrect raw material.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1062-2014 |
| Date reported | February 26, 2014 |
| Date initiated | October 16, 2013 |
| Recalling firm | Bausch & Lomb Surgical, Inc. |
| Firm location | Clearwater, FL |
| Affected scope | 336 IOLs (283 IOLs in the US, 53 IOLs outside the US) |
| Distribution | Worldwide Distribution: US (nationwide) and Internationally to: Great Britain, France, Spain, Portugal, Sweden, Russia and Guadeloupe. |
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-1062-2014) 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? ▼
Bausch & Lomb AKREOS AO Micro Incision Lens The Akreos IOL intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients.. Recalled by Bausch & Lomb Surgical, Inc.. Units affected: 336 IOLs (283 IOLs in the US, 53 IOLs outside the US).
Why was this product recalled? ▼
Lens was manufactured with incorrect raw material.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 26, 2014. Severity: Moderate. Recall number: Z-1062-2014.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution: US (nationwide) and Internationally to: Great Britain, France, Spain, Portugal, Sweden, Russia and Guadeloupe..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1062-2014) 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 February 26, 2014. 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.