TearCare version 1.0 SmartHubs
FDA Recall Z-1001-2022 · Posted None
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Recalling FirmSight Sciences, Inc.
Recall StatusOpen, Classified
Product CodeORZ
Date Initiated2022-03-23
Product Quantity921
Reason for Recall
Ophthalmic devices distributed prior to the recently-obtained 510(k) clearance do not fall within the relevant 510(k) exemption and so their performance characteristics were not evaluated by the FDA prior to distribution.
Firm Action
On 03/23/22, recall notices were mailed to customers who were informed that the recalling firm intends to send new 510(k)-cleared devices, version 1.5, to replace affected devices. Customers were asked to do the following:
1) After receiving the new devices, return the affected devices to the recalling firm.
2) Complete and return the response form.
Customers questions can contact customer service at: 877-266-1144 or [email protected]
Root Cause
No Marketing Application
Distribution Pattern
US Nationwide distribution in the states of PA, CA, OH, AZ, CT, NC, GA, TN, MS, RI, WA, IL, FL, NV, NE, VA, SD, KY, OK, NJ, CO, TX, MI, NY, AR, WI, OR, MO, AL, NM, UT, WV, SC, IN, KS, MA, MN, NH, MT, ND, MD, WY, HI, DC, ID, LA, DE.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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