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U.S. Department of Health and Human Services

Class 2 Device Recall VISULENS 550

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  Class 2 Device Recall VISULENS 550 see related information
Date Initiated by Firm August 06, 2020
Create Date December 16, 2020
Recall Status1 Open3, Classified
Recall Number Z-0613-2021
Recall Event ID 86366
Product Classification Instrument, measuring, lens, ac-powered - Product Code HLM
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.
Code Information Model: VISUREF 150 Catalog Number: 000000-2227-967 Serial Numbers: Pending
Recalling Firm/
Manufacturer		 Carl Zeiss Meditec AG
Carl-Zeiss-Promenade 10
Jena Germany
Manufacturer 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.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On 08/18/2020, the firm sent an "URGENT MEDICAL DEVICE RECALL" Notification Letter via FedEx overnight informing customers that based on post market surveillance activities, the Recalling Firm found that the communication board on their digital lensmeter and autorefractor were not performing as expected and needs to be exchanged as a precautionary measure. In rare cases the RS232 communication port can fail on the communication board. Both products use the same technology. In the worst-case situation, the safety function of the communication board is insufficient when a connected third-party device is causing an electrical overload at the RS232 interface. This could result in an increased leakage current and electrical shock for the user / patient. If the communication board fails without connecting a third-party device, a burning smell can occur as a result of a thermal event. Customers are to note that the outer housing materials of the lensmeter and autorefractor fulfill the normative requirement concerning flammability. Actions to be taken by the Customer/User: The Recalling Firm is asking customers to disconnect all non-medical grade devices from the affected device RS232 interfaces. If the affected devices are connected to a digital phoropter a disconnection is not needed. Furthermore, the Recalling Firm is asking customers to switch off the affected devices when customers cannot supervise the device, especially when they close their location after working hours. Customers will receive additional information about the handling of this recall from their local service organization. The Recalling Firm is planning to replace the affected component at the next available opportunity. For questions regarding this Recall, contact Customer Support at 877-486-7473.
Quantity in Commerce 603 units
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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