| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00222-1 |
| Product Name/Description |
Alcon Custom Pak containing Oasis Medical 27G Chang Hydrodissection Cannulas
Catalogue number: AS17612-04
Batch numbers: 15VHD9, 15YCE7, 162Y51, 1689L2, 16F3H5, 16H1HX, 16J9TX, 16DU4M
ARTG 370933
(Alcon Laboratories Australia Pty Ltd - Surgical procedure kit, ophthalmic, non-medicated, single-use) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
25/03/2024 |
| Responsible Entity |
|
| Reason/Issue |
Alcon is aware of customer complaint samples that have revealed foreign material, occlusions and bent tips for these cannulas.
Alcon has determined that in the event that the foreign material is not identified prior to surgery or is not fully irrigated from within the eye during the surgical procedure, an inflammatory response may occur.
In the worst-case scenario, if an occlusion or severely bent tip is present on the 27G Chang Hydrodissection Cannula, and not detected prior to surgery, there is a potential for ocular tissue damage to occur (e.g. capsular tear, zonular damage, iris trauma).
Based on the complaint sample evaluation Alcon has determined that the foreign material is not microbial in nature. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Upon opening your Custom Pak for surgical use, please remove and dispose of the 27G Chang Hydrodissection Cannula contained within the specific lot(s) of Alcon Custom Paks affected. Customers should use a separate sterile stand-alone cannula from their own inventory or that supplied by Alcon.
NOTE: Alcon Custom Pak units are sterile and should not be opened prior to surgery. The remaining components of the Alcon Custom Pak are unaffected by this Product Defect Correction and can be used as intended.
Affected lots of packs in our Australian distribution centre will be placed on hold and stickered to identify it as an affected pack and shipped with a sterile stand-alone substitution. |
| Contact Information |
1800 224 153 - Alcon Australia Customer Service |