Product Safety Recalls

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Sight Sciences, Inc. Recall 89939

Description: TearCare version 1.0 SmartHubs

Sight Sciences, Inc. Recall 89939 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1001-2022
Event ID89939
Event DescriptionTearCare version 1.0 SmartHubs
Product TypeDevices
DistributionUS 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.
Quantity921
Recall ReasonOphthalmic 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.
Device Classification20220504
Device Code InfoUDI/DI: 00858027006273; Lots: 1007076 through 1007406, 133914 through 137646, and 846004203 through 846237811.
Center Classification Date20220425
Recall Initiation Date20220323
Recalling FirmSight Sciences, Inc.
Initial Notification Letter
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