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Beaver Visitec International, Inc. Recall 89111

Description: Malosa Core SMILE Pack 1-Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK884

Beaver Visitec International, Inc. Recall 89111 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0409-2022
Event ID89111
Event DescriptionMalosa Core SMILE Pack 1-Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK884
Product TypeDevices
DistributionCA, CO, LA, MA, MD, ND, PA, TN, UT
Quantity680 units
Recall ReasonKit packaging may have small holes compromising product sterility
Device Classification20211229
Device Code InfoLot Numbers: 3261518, 3272335, 3278550, 3292632, 3305153, 3326272, 3331632, 3334880, 3344465, 3348295, 3350319, 3357568, 3362608, 3363639
Center Classification Date20211221
Recall Initiation Date20211117
Recalling FirmBeaver Visitec International, Inc.
Initial Notification Letter
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