The Recall Desk
HighFDA (Devices)·Z-1007-2023·Announced 2023-02-01

Surgical vision packs with defective welds may affect cataract surgery outcomes

Johnson & Johnson is recalling 384 single-use phacoemulsification packs due to weld defects that may cause surgical delays and corneal swelling during cataract surgery.

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: FDA Class II recall of a surgical device with manufacturing defects that could result in surgical complications including corneal edema. No illnesses or injuries reported; hazard is risk-of-harm based on product defect without documented patient harm.

Plain-English summary

Johnson & Johnson Surgical Vision, Inc. is recalling 384 single-use phacoemulsification packs (REF: OPO80, Lot 05050474573352/60326033) used in cataract surgery. The packs have weld defects and physical gaps between the housing and pack cover that may exceed design specifications.

These defects could prevent the priming cycle from completing properly and may reduce the vacuum delivered to surgical handpieces during the procedure. This could result in surgical delays, extended surgical time, and increased risk of transient corneal edema (swelling of the cornea).

The affected units have been distributed in the United States (Florida, Mississippi, New York, Tennessee, Texas, Illinois, Minnesota, Ohio) and internationally to Belgium, China, Estonia, France, Germany, Indonesia, Italy, Japan, Malaysia, Netherlands, Portugal, Sri Lanka, Switzerland, Thailand, and the United Kingdom.

No illnesses or injuries have been reported. Affected facilities should stop using these packs and contact Johnson & Johnson Surgical Vision for replacement units or further instructions.

The recalled product

Product
Single-Use Packs, REF: OPO80
Manufacturer
Johnson & Johnson Surgical Vision, Inc.
Category
Medical Device — Surgical / Phacoemulsification
Hazard
Affected units
384

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 (1)

  • UDI-DI/Lot: 05050474573352/60326033

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 · defective weld

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