The Recall Desk
HighFDA (Devices)·Z-1006-2023·Announced 2023-02-01

FUSION Dual Pump Packs recalled for weld defect affecting surgery

FUSION Dual Pump Packs are being recalled for weld defects that may impair vacuum delivery during eye surgery, risking surgical delays and corneal swelling. No injuries have been reported.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall with no reported hospitalizations or injuries. The device malfunction could theoretically cause transient corneal edema, but this has not been reported to occur, making it a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Johnson & Johnson Surgical Vision, Inc. is recalling FUSION Dual Pump Pack surgical devices (model OPO73) used in cataract surgery. The devices contain weld defects—specifically, protrusions or gaps between the housing and cover that exceed design specifications.

These defects can prevent the pump pack from functioning properly during surgery, potentially failing to deliver adequate vacuum pressure to the surgical instruments. This could lead to surgical delays and transient corneal edema (temporary eye swelling).

A total of 7,644 affected devices were distributed across the United States (Florida, Mississippi, New York, Tennessee, Texas, Illinois, Minnesota, and Ohio) and internationally (Belgium, China, Estonia, France, Germany, Indonesia, Italy, Japan, Malaysia, Netherlands, Portugal, Sri Lanka, Switzerland, Thailand, and United Kingdom).

The recalled product

Product
FUSION Dual Pump Packs, REF: OPO73
Manufacturer
Johnson & Johnson Surgical Vision, Inc.
Category
Medical Device — Ophthalmic surgical
Hazard
Affected units
7,644

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)

  • UDI-DI/Lots: 15050474602080/60373238
  • 60394037
  • 60308197

Distribution

Distributed in 8 states:

Part of a larger recall action

This product is one of 3 recalled by Johnson & Johnson Surgical Vision, 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 3 products in this recall →

Related recalls

Same manufacturer · Johnson & Johnson Surgical Vision, Inc.

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Same hazard · corneal edema

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