# FDA recall Z-0613-2021

> **Carl Zeiss Meditec AG** · Class II · device recall initiated 2020-08-06.

## Product

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.

## 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.

## Distribution

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.

## Key facts

- **Recall number:** Z-0613-2021
- **Recalling firm:** Carl Zeiss Meditec AG
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-08-06
- **Report date:** 2020-12-23
- **Termination date:** 2024-12-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Jena, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0613-2021

## Citation

> AI Analytics. FDA recall Z-0613-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0613-2021. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*