Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 27, 2013
Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular
The user database delivered for download contained an erroneous value. Specifically the "aO" constant of the lens AMO Sensar AR40E is listed as "0.0" in the internal lens database…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Carl Zeiss Meditec, Inc. recalled Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is … - a moderate-severity action.
Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is … was recalled by Carl Zeiss Meditec, Inc. in November 27, 2013. Reason: The user database delivered for download contained an erroneous value. Specifically the "aO" constant of the …. Check the official notice for the remedy. Verify recall #Z-0333-2014 with the FDA Devices before acting.
The recall
Carl Zeiss Meditec, Inc. issued this moderate-severity FDA Devices recall-The user database delivered for download contained an erroneous value. Specifically the "aO" constant of the ….
- Moderate
- severity level
- 5K units
- affected scope
- Class II
- classification
- November 27, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0333-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0333-2014) was formally reported on November 27, 2013, with the manufacturer initiating the action on October 23, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Carl Zeiss Meditec, Inc. is listed as the recalling firm, operating out of Dublin, CA. Federal records list the affected scope as 4,907 units.
The documented reason for this recall is: The user database delivered for download contained an erroneous value. Specifically the "aO" constant of the lens AMO Sensar AR40E is listed as "0.0" in the internal lens database of the IOLMaster. The correct value is … Distribution data in the federal record shows the product reached: Nationwide distribution.. 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
4,907 units
Related Recalls
6
3 from same agency
Product description
Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation
Reason for recall
The user database delivered for download contained an erroneous value. Specifically the "aO" constant of the lens AMO Sensar AR40E is listed as "0.0" in the internal lens database of the IOLMaster. The correct value is -2.420. This could lead to the implantation of lens with a wrong diopter value.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0333-2014 |
| Date reported | November 27, 2013 |
| Date initiated | October 23, 2013 |
| Recalling firm | Carl Zeiss Meditec, Inc. |
| Firm location | Dublin, CA |
| Affected scope | 4,907 units |
| Distribution | Nationwide distribution. |
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-0333-2014) 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? ▼
Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation. Recalled by Carl Zeiss Meditec, Inc.. Units affected: 4,907 units.
Why was this product recalled? ▼
The user database delivered for download contained an erroneous value. Specifically the "aO" constant of the lens AMO Sensar AR40E is listed as "0.0" in the internal lens database of the IOLMaster. The correct value is -2.420. This could lead to the implantation of lens with a wrong diopter value.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 27, 2013. Severity: Moderate. Recall number: Z-0333-2014.
Where was the recalled product distributed? ▼
Distribution: Nationwide distribution..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0333-2014) 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 November 27, 2013. 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.