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U.S. Department of Health and Human Services

Class 2 Device Recall CustomEyes

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 Class 2 Device Recall CustomEyessee related information
Date Initiated by FirmDecember 20, 2022
Date PostedMarch 01, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1200-2023
Recall Event ID 91488
Product Classification Kit, surgical instrument, disposable - Product Code KDD
ProductCustomEyes kits
Code Information Catalog #BVI-58001086 and BVI-58001089, Lot Numbers 6051841, 6052299, 6051842, 6052300 UDI/DI: 50886158021990 and 50886158021969
FEI Number 1211998
Recalling Firm/
Manufacturer		 Beaver Visitec International, Inc.
500 Totten Pond Rd
10 City Point
Waltham MA 02451-1916
For Additional Information ContactMs. Aminah Crawford
781-906-7950
Manufacturer Reason
for Recall		Device packaging may contain open seals, compromising product sterility.
FDA Determined
Cause 2		Process control
ActionA consignee letter was issued to impacted customers on January 18, 2023. The communication advises consignees to immediately examine inventory and quarantine product from impacted lots. If further distribution has occurred, a sub-recall should be initiated. A completed copy of the Business Response Form shall be completed and returned to beavervisitec8978@sedgwick.com.
Quantity in Commerce4640 units in total
DistributionUS distribution in AL, CA, CO, DC, FL, GA, IL, LA, MD, MN, MT, NC, NH, NJ, NM, NY, OH OK, PA, RI, TN, TX, UT, VA, VT, WA, and WI OUS distribution to Canada, Japan, and South Africa
Total Product Life CycleTPLC 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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