Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported February 24, 2021
IOLMaster 700
When using software 1.90.2.09 or 1.90.8.06 and using modality worklist functionality for patient data transfer, the selection of the patient in the patient list may not match the …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Carl Zeiss Meditec Ag recalled IOLMaster 700 - a moderate-severity action.
IOLMaster 700 was recalled by Carl Zeiss Meditec Ag in February 24, 2021. Reason: When using software 1.90.2.09 or 1.90.8.06 and using modality worklist functionality for patient data transfe…. Check the official notice for the remedy. Verify recall #Z-1133-2021 with the FDA Devices before acting.
The recall
Carl Zeiss Meditec Ag issued this moderate-severity FDA Devices recall-When using software 1.90.2.09 or 1.90.8.06 and using modality worklist functionality for patient data transfe….
- Moderate
- severity level
- 613 units
- affected scope
- Class II
- classification
- February 24, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1133-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1133-2021) was formally reported on February 24, 2021, with the manufacturer initiating the action on December 7, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Carl Zeiss Meditec Ag is listed as the recalling firm, operating out of Jena, N/A. Federal records list the affected scope as 613 devices.
The documented reason for this recall is: When using software 1.90.2.09 or 1.90.8.06 and using modality worklist functionality for patient data transfer, the selection of the patient in the patient list may not match the patient information displayed on the rig… Distribution data in the federal record shows the product reached: U.S.: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, Puerto Rico, SC, TX, UT, VA, VT, WA, WI, and WV. O.U.S.: Austria, Australia, Canada, Switz…. 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
613 devices
Related Recalls
6
3 from same agency
Product description
IOLMaster 700
Reason for recall
When using software 1.90.2.09 or 1.90.8.06 and using modality worklist functionality for patient data transfer, the selection of the patient in the patient list may not match the patient information displayed on the right side of the screen
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1133-2021 |
| Date reported | February 24, 2021 |
| Date initiated | December 7, 2020 |
| Recalling firm | Carl Zeiss Meditec Ag |
| Firm location | Jena, N/A |
| Affected scope | 613 devices |
| Distribution | U.S.: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, Puerto Rico, SC, TX, UT, VA, VT, WA, WI, and WV. O.U.S.: Austria, Australia, Canada, Switzerland, Czech Republ… |
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-1133-2021) 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? ▼
IOLMaster 700. Recalled by Carl Zeiss Meditec Ag. Units affected: 613 devices.
Why was this product recalled? ▼
When using software 1.90.2.09 or 1.90.8.06 and using modality worklist functionality for patient data transfer, the selection of the patient in the patient list may not match the patient information displayed on the right side of the screen
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 24, 2021. Severity: Moderate. Recall number: Z-1133-2021.
Where was the recalled product distributed? ▼
Distribution: U.S.: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, Puerto Rico, SC, TX, UT, VA, VT, WA, WI, and WV. O.U.S.: Austria, Australia, Canada, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, France, United Kingdom, Guatemala, Hong Kong, Indonesia, Ireland, India, Italy, Japan, Kuwait, Malaysia, Netherlands, New Zealand, Philippines, Poland, Portugal, Russia, Sweden, Singapore, Slovakia, Thailand, Taiwan, and South Africa..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1133-2021) 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 24, 2021. 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.