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.

Recall #: Z-1062-2014
Affected scope: 336 IOLs (283 IOLs in the US, 53 IOLs outside the US)
Initiated: October 16, 2013

Compiled from official public sources by the publisher. · Updated September 2026

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 recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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, 6 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.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.

Product description

Reason for recall

Lens was manufactured with incorrect raw material.

Recall Profile

Structured summary of the FDA Devices recall record
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..

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.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

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Similar Medical Devices · nearest report date

Same product category, closest by report date among other firms and states (deduped against the severity set).

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This recall: FDA Devices, reported February 26, 2014. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026