Recall Z-0614-2021 ยท HKO Refractometer, Ophthalmic
Carl Zeiss Meditec AG
Carl Zeiss Meditec AG VISUREF150 REF 2227-967 - Product Usage: is a diagnostic instrument used to determine the objective refractive values and keratometric characteristics of the human eye. The results are used to assist the process of prescribing optical aids such as eyeglasses and contact lenses.
| Date | Aug 6, 2020 |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 |
| Quantity | 132 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, C |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.