Bausch and Lomb Amvisc Cannulas Recalled for Detachment Risk
Bausch and Lomb is recalling Amvisc and Amvisc Plus cannulas that may detach from syringes during injection, posing a risk of serious patient injury.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states that in rare incidents, the defect has resulted in serious patient injury, which aligns with the rubric criteria for a Severe (4) rating involving significant injury reports.
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…
- Manufacturer
- Bausch and Lomb, Incorporated
- Hazard
- 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.
Lot numbers (20)
- Lot Numbers: 23632
- 23633
- 23639
- 23640
- 23647
- 23801
- 23811
- 23863
- 23886
- 23897
- 23920
- 23933
- 23972
- 24022
- 24025
- 24028
- 24257
- 24323
- 24436
- B100003C
Distribution
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