| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00180-1 |
| Product Name/Description |
Hydrophilic Acrylic Single Use lntraocular Lens system packs
Product Model Number.: 623T
Batch Numbers: 65190, 64525, 64529, 64720, 65224, 65224, 65251, 65544
ARTG Number: 100926
Product Model Number: 653L
Batch Number: 65122
ARTG Number: 1752621 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
23/03/2015 |
| Responsible Entity |
|
| Reason/Issue |
Rayner through Kevin Grundy (IBD) Pty Ltd is informing the customers that certain products released to market contain an injector (individually wrapped within the product carton) that has a slightly shorter expiry date than the expiry date as shown on the outer carton. The affected lots may have an expiry date (on the outer carton) of November 2019, December 2019 or January 2020), The individually wrapped injector has its own expiry date marked on the tyvek lid. The expiry date of the associated injectors is around one month prior to that shown on the outer carton.There is no immediate issue associated with the use of the product. The affected product will not expire at least for four year and eight months. |
| Recall Action |
Recall |
| Recall Action Instructions |
Kevin Grundy (IBD) Pty Ltd (for Rayner) is requesting the customers to return all the affected units. Rayner Intraocular Lenses Limited offers free replacementfor the products that are not intended to be used in the short term.
This action has been closed out on the 09/10/2018, |
| Contact Information |
02 9550 6966 - Sean Hutchings |