Z-0410-2022Class II

Malosa Core SMILE Pack 2-Beaver-Visitec- A Medical Refractive Kit intended to be used to aid in cataract...

Name: Z-0410-2022 Malosa Core SMILE Pack 2-Beaver-Visitec- A Medical Refractive Kit intended to be used to aid in cataract...
Creator: Beaver Visitec International, Inc.
Published: 2021-11-17
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2021-11-17 / Open, Classified / root cause: packaging

FDA source

Beaver Visitec International, Inc. began a recall of 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 on 2021-11-17. FDA classified it as Class II and gives the reason as "Kit packaging may have small holes compromising product sterility". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0410-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-11-17
Posted: 2021-12-21
Recalling firm: Becton Dickinson & Co
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
Product code: PZG Surgical Eye Tray
Reason for recall: Kit packaging may have small holes compromising product sterility
Root cause tag: packaging
FDA root 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 [email protected] 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
Product codes and lots: Lot Numbers: 3347922, 3350452, 3354937, 3358047, 3364371

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0410-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0405-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-12-29	2021-12-21
Z-0406-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-12-29	2021-12-21
Z-0407-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-12-29	2021-12-21
Z-0408-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-12-29	2021-12-21
Z-0409-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-12-29	2021-12-21
Z-0410-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-12-29	2021-12-21

Product code PZG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)