—#190543

Product

Malosa Core LASIK Pack 2-Medical Refractive Kit- intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK100/2

FDA product code: PZG — Surgical Eye Tray
Device class: Class 1
Medical specialty: Ophthalmic
Affected lot / code info: Lot Numbers: 3309015, 3347920, 3351630, 3356836, 3360219, 3364419

Why it was recalled

Kit packaging may have small holes compromising product sterility

Root cause (FDA determination)

Packaging change control

Action the firm took

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).

Recalling firm

Firm: Beaver Visitec International, Inc.
Address: 500 Totten Pond Rd, 10, City Point Waltham, Massachusetts 02451-1916

Distribution

Distribution pattern: CA, CO, LA, MA, MD, ND, PA, TN, UT

Timeline

Recall initiated: 2021-11-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #190543. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.