FDA recalls BVI CustomEyes Procedure Packs with Sol-M syringes
The FDA is issuing a voluntary recall of BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes affecting 1,029 units distributed nationwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a voluntary Class II medical device recall with no reported illnesses, injuries, or deaths. Voluntary precautionary recalls are classified as Moderate severity per the rubric.
Plain-English summary
The FDA has issued a voluntary recall of BVI CustomEyes Procedure Packs that contain low dead space syringes and luer slip tip syringes manufactured by Sol-Millennium Medical (Sol-M), Inc. These syringes are present in some BVI CustomEyes Procedure Packs.
The affected product is BVI CustomEyes Procedure Packs Part Number 58001622, with lot numbers 6062867 and 6072189. Approximately 1,029 units have been distributed nationwide in the United States.
Healthcare facilities and eye care providers who have these procedure packs should contact Beaver Visitec International, Inc., for instructions regarding this recall. Patients and healthcare professionals who believe they have experienced problems related to this recall should report them to the FDA.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001622;
- Manufacturer
- Beaver Visitec International, Inc.
- Hazard
- syringe-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Part Number: 58001622
- UDI-DI: 30886158031728
- Lot/Batch Number: 6062867
- 6072189
Distribution
Distributed nationwide across the United States.
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