The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2814-2024·Announced 2024-09-04

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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.
Category
Medical Device — Surgical Syringes
Hazard
Affected units
105

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.

Part of a larger recall action

This product is one of 159 recalled by Beaver Visitec International, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 159 products in this recall →

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