Class 2 Device Recall

• Date Initiated by Firm: November 17, 2021
• Create Date: December 21, 2021
• Recall Status: Open, Classified
• Recall Number: Z-0410-2022
• Recall Event ID: 89111
• Product Classification: Surgical eye tray - Product Code PZG
• Product: Malosa Core SMILE Pack 2-Beaver-Visitec- A Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK967
• Code Information: Lot Numbers: 3347922, 3350452, 3354937, 3358047, 3364371
• FEI Number: 1211998
• Recalling Firm/ Manufacturer: Beaver Visitec International, Inc.; 500 Totten Pond Rd; 10 City Point; Waltham MA 02451-1916
• For Additional Information Contact: SAME; 781-906-7950
• Manufacturer Reason for Recall: Kit packaging may have small holes compromising product sterility
• FDA Determined Cause: Packaging change control
• Action: Beaver Visitec issued Urgent Medical Device Recall notification dated 11/17/21 to the first level consignee. Letter states reason for recall, health risk and action to take: PLEASE perform the following actions: 1. Immediately examine your inventory and quarantine product from these lots that are subject to recall. If you have further distributed this product, please notify your customers by initiating a sub-recall. Consider all potential users of this product in your user supply chain. You are encouraged to use a copy of this recall notification letter when contacting your customers. 2. Complete the enclosed Business Reply Form (BRF) and indicate whether you have affected product to return. 3. Please enter the following information on the enclosed BRF: part number(s), lot number(s) and quantity(ies) of device(s) that are being returned. 4. Return the completed BRF to BVI by one of these methods: " Fax to 866-912-8416 " Email the attached to beavervisitec3570@sedgwick.com 5. Return your product to STERICYCLE using the enclosed UPS pre-paid return label: Stericycle 2670 Executive Drive, Suite A Indianapolis, IN 46241 Attn: Event 3570 If you have questions regarding the return procedure, please contact Stericycle Inc. at 866-625-5325 (Mon.-Fri. 8:00 am - 5:00 pm Eastern Time).
• Quantity in Commerce: 1170 units
• Distribution: CA, CO, LA, MA, MD, ND, PA, TN, UT
• Total Product Life Cycle: TPLC 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.