Recall Z-0410-2022— Beaver Visitec International, Inc.
Class II · Ongoing
Class II FDA medical device recall by Beaver Visitec International, Inc., initiated 2021-11-17. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: Kit packaging may have small holes compromising product sterility.
- Recalling firm
- Beaver Visitec International, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-11-17
- Firm location
- Waltham, MA, United States
Product description
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
Reason for recall
Kit packaging may have small holes compromising product sterility
Data sourced from openFDA. This site is unofficial and independent of the FDA.