HEALON EndoCoat PRO
Last updated
Summary
Product
HEALON EndoCoat PRO
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| HEALON EndoCoat PRO | UA32371 | 10-3000-12 |
| HEALON EndoCoat PRO | UA32303 | 10-3000-12 |
| HEALON EndoCoat PRO | UP31203 | 10-3000-12 |
| HEALON EndoCoat PRO | UP31205 | 10-3000-12 |
| HEALON EndoCoat PRO | UA32292 | 10-3000-12 |
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.
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Ophthalmology
Companies
| Johnson & Johnson Surgical Vision, Inc. |
| 31 Technology Drive, Irvine, California, United States, 92618 |
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-82444
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