Recall Monitor
Health Products

HEALON EndoCoat PRO

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Ophthalmology
Product: HEALON EndoCoat PRO
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
HEALON EndoCoat PROUA3237110-3000-12
HEALON EndoCoat PROUA3230310-3000-12
HEALON EndoCoat PROUP3120310-3000-12
HEALON EndoCoat PROUP3120510-3000-12
HEALON EndoCoat PROUA3229210-3000-12

Issue

Johnson & Johnson Surgical Vision, Inc. is issuing a voluntary recall notice for HEALON EndoCoat™ PRO to inform customers of reports involving difficulty with insertion of the ultra-thin 25g orange cannula. This notice is intended to communicate the potential risks associated with cannula insertion and provide additional clarification regarding insertion technique to support the safe and effective use of the product. This recall does not require removal or return of the product from the market. When used in accordance with the instructions provided in this notice, the product may continue to be used as intended.

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