Malosa Core SMILE Pack 1-Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK884
Reported: December 29, 2021 Initiated: November 17, 2021 #Z-0409-2022
Product Description
Malosa Core SMILE Pack 1-Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK884
Reason for Recall
Kit packaging may have small holes compromising product sterility
Details
- Recalling Firm
- Beaver Visitec International, Inc.
- Units Affected
- 680 units
- Distribution
- CA, CO, LA, MA, MD, ND, PA, TN, UT
- Location
- Waltham, MA
Frequently Asked Questions
What product was recalled? ▼
Malosa Core SMILE Pack 1-Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK884. Recalled by Beaver Visitec International, Inc.. Units affected: 680 units.
Why was this product recalled? ▼
Kit packaging may have small holes compromising product sterility
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 29, 2021. Severity: Moderate. Recall number: Z-0409-2022.
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