Bausch and Lomb Amvisc Cannulas Recalled for Detachment Risk

Plain-English summary

Bausch and Lomb, Incorporated is recalling specific 27G sterile cannulas packed with the Amvisc 1.2% Sodium Hyaluronate and Amvisc Plus 1.6% Sodium Hyaluronate ophthalmic viscosurgical devices. The recall involves approximately 2.5 million units distributed worldwide, including the United States, Canada, and Mexico.

The recall is due to a defect where the disposable cannulas do not properly engage with the Luer-Lock fitting on the sterile glass syringes. This failure can cause the cannulas to leak viscoelastic material or detach from the syringe during injection. The source notes that in rare incidents, this detachment has resulted in serious patient injury.

Healthcare providers and patients should stop using the affected cannulas immediately. The affected products are identified by specific 4-digit lot numbers and model numbers listed in the official recall documentation. Users should contact Bausch and Lomb for instructions on returning the product or obtaining a replacement.

The recalled product

Product

Bausch and Lomb 27G sterile cannula packed in the Bausch and Lomb Amvisc 1.2% Sodium Hyaluronate ( Model 59051, 59081, 59051L, 59081L) and Amvisc Plus 1.6% Sodium Hyaluronate (Model 60081, 60051, 60051L, 60081L) ophthalmic viscosurgical device. The 27G disposable cannula is a

Manufacturer

Bausch and Lomb, Incorporated

Category

Medical Device — Ophthalmic Surgical Device

Hazard

• device-detachment
• injury

Affected units

2,515,760

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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