| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00525-1 |
| Product Name/Description |
Healon Ophthalmic Viscosurgical Devices (OVD) 0.55mL
Lot Number: UB32514
ARTG Number: 144891 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
26/04/2017 |
| Responsible Entity |
|
| Reason/Issue |
AMO has identified the remote possibility that certain Healon 0.55ml solutions in the affected lot may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process. Use of OVD solutions with glass particles could potentially lead to intraocular injury. To date, no patient injuries have been reported to AMO in connection with any of the affected Healon 0.55ml. |
| Recall Action |
Recall |
| Recall Action Instructions |
AMO Australia is advising users to immediately stop using and remove the affected Healon 0.55ml lot from their inventory. Distributors are to stop shipping this lot. Product is to be returned to AMO for replacement.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
02 9855 0118 - AMO Australia |