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.
Enforcement
- Recall Number
- Z-0613-2021
- Event ID
- 86366
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Carl Zeiss Meditec AG
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 23, 2020
- Initiation Date
- August 6, 2020
- Classification Date
- December 16, 2020
- Termination Date
- December 13, 2024
- Address
- Carl-Zeiss-Promenade 10, N/A, Jena, N/A, N/A, Germany
Description
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.
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.
Model: VISUREF 150 Catalog Number: 000000-2227-967 Serial Numbers: Pending
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.
603 units