CLASS II Device recall · Reported 24 Feb 2021 · FDA Enforcement Report
IOLMaster recalled by Carl Zeiss Meditec AG
Carl Zeiss Meditec is recalling IOLMaster 700, distributed in 39 states. The recall was initiated on 7 Dec 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1133-2021
- FDA event ID
- 87055
- Recalling firm
- Carl Zeiss Meditec, Jena, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Dec 2020
- FDA classified
- 18 Feb 2021
- Reported
- 24 Feb 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 7 Dec 2020 | Recall initiated by company | |
| 18 Feb 2021 | Classified by FDA | +73 days |
| 24 Feb 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
IOLMaster 700
Where it was distributed
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.
AlabamaArkansasArizonaCaliforniaColoradoConnecticutDelawareFloridaGeorgiaIowaIllinoisIndianaKansasLouisianaMassachusettsMarylandMaineMichiganMissouriMississippi
Questions about this recall
Why was it 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 lots are affected?
Model: IOLMaster 700 Catalog Number device: 000000-1932-169
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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