CLASS II Device recall · Reported 23 Dec 2020 · FDA Enforcement Report
Carl Zeiss Meditec Ag Visulens recalled
Carl Zeiss Meditec AG is recalling Carl Zeiss Meditec Ag Visulens 550, distributed nationwide in the US. The recall was initiated on 6 Aug 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-0613-2021
- FDA event ID
- 86366
- Recalling firm
- Carl Zeiss Meditec AG, Jena, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Aug 2020
- FDA classified
- 16 Dec 2020
- Reported
- 23 Dec 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Contact Lenses & Eye Devices
Timeline
| 6 Aug 2020 | Recall initiated by company | |
| 16 Dec 2020 | Classified by FDA | +132 days |
| 23 Dec 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to the incorrect DC/DC converter being assembled onto the communication board. As a result the effectiveness of the communication board cannot be guaranteed in that the safety function of the board would be insufficient resulting in an increased leakage of current and potentially cause electrical shocks to the user.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Carl Zeiss Meditec Ag VISULENS 550 REF 2268-038 - Product Usage: is a device for measuring the refractive power of contact lenses and spectacle lenses and displaying measurement values for sphere, cylinder and prism.
Where it was distributed
Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MD, MI, MN, NC, NE, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, TX, UT, VA, WA and WY. The countries of Argentina, Austria, Australia, Belgium, Bolivia, Canada, Colombia, Croatia, Cyprus, Denmark, France, Germany, Hong Kong, Hungary, India, Ireland, Italy, Japan, Latvia, Luxembourg, Malaysia, Maldives, Netherlands, Portugal, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Turkey, and United Kingdom.
Nationwide AlabamaArkansasArizonaCaliforniaColoradoConnecticutDelawareFloridaGeorgiaHawaiiIdahoIllinoisIndianaKansasKentuckyLouisianaMarylandMichiganMinnesotaNorth Carolina
Questions about this recall
Is Carl Zeiss Meditec Ag Visulens 550 recalled?
Yes. Carl Zeiss Meditec AG recalled Carl Zeiss Meditec Ag Visulens 550 on 6 Aug 2020. The recall is Class II and its status is Terminated. Recall number Z-0613-2021.
Why was it recalled?
Due to the incorrect DC/DC converter being assembled onto the communication board. As a result the effectiveness of the communication board cannot be guaranteed in that the safety function of the board would be insufficient resulting in an increased leakage of current and potentially cause electrical shocks to the user.
Which lots are affected?
Model: VISUREF 150 Catalog Number: 000000-2227-967 Serial Numbers: Pending
Where was it sold?
Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MD, MI, MN, NC, NE, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, TX, UT, VA, WA and WY. The countries of Argentina, Austria, Australia, Belgium, Bolivia, Canada, Colombia, Croatia, Cyprus, Denmark, France, Germany, Hong Kong, Hungary, India, Ireland, Italy, Japan, Latvia, Luxembourg, Malaysia, Maldives, Netherlands, Portugal, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Turkey, and United Kingdom.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Carl Zeiss Meditec AG
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|---|---|---|---|---|---|
| Device | CLASS II | Zeiss Intrabeam Spherical Applicator recalled by Carl Zeiss Meditec AG | Carl Zeiss Meditec AG | Other | Nationwide |
| Device | CLASS II | Zeiss miLOOP Lens Fragmentation Device recalled by Carl Zeiss Meditec AG | Carl Zeiss Meditec AG | Other | 32 states |
| Device | CLASS II | IOLMaster recalled by Carl Zeiss Meditec AG | Carl Zeiss Meditec AG | Device Malfunction | 39 states |
| Device | CLASS II | Carl Zeiss Meditec AG VISUREF150 recalled | Carl Zeiss Meditec AG | Foreign Material | Nationwide |
| Device | CLASS II | Carl Zeiss Meditec AG, Goeschwitzer Strasse recalled | Carl Zeiss Meditec AG | Other | CA |
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