FDA Recalls BVI CustomEyes Eye Surgery Procedure Packs
Beaver Visitec International voluntarily recalls BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical. Approximately 105 units were 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: FDA Class II medical device recall with no reported illnesses, injuries, or deaths. The manufacturer initiated a voluntary recall due to recalled syringe components. With no harm reports and the precautionary nature of the action, this meets the criteria for moderate severity per the rubric.
Plain-English summary
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes (Part Number 58000568, Lot Number 6069614) are being voluntarily recalled by Beaver Visitec International, Inc. The syringes contained in these procedure packs were manufactured by Sol-Millennium Medical (Sol-M), Inc. Approximately 105 units were distributed nationwide in the United States.
The recall was initiated due to a voluntary recall of Sol-M low dead space syringes and luer slip tip syringes that are components of these procedure packs.
Consumers who have purchased affected procedure packs should stop using them and contact Beaver Visitec International, Inc. for instructions on returning recalled units.
The recalled product
- Product
- BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000568;
- Manufacturer
- Beaver Visitec International, Inc.
- Hazard
- device-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 (3)
- Part Number: 58000568
- UDI-DI: 30886158020432
- Lot/Batch Number: 6069614
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- SevereAbiomed Automated Impella Controller recalled for motor control and pump failure risks
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03