| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00044-2 |
| Product Name/Description |
Rayner Intraocular Lenses - Sulcoflex Aspheric 653L, Sulcoflex Torie 653T, C-flex Aspheric 970C, Superflex Aspheric 920H, Sulcoflex Aspherie 653L, T-flex Aspheric 623T
Multiple Models and Lot Numbers affected
ARTG Number: 100926 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
13/01/2016 |
| Responsible Entity |
|
| Reason/Issue |
Internal quality checks by the manufacturer Rayner have revealed that certain products released to market may contain a higher than usual level of residual polishing compound (aluminium oxide) that is used in the manufacturing process of intraocular lenses (IOLs).
There is a possibility that certain products released to market may contain levels that slightly exceed the internal limits for residual aluminium oxide levels. Clinically significant levels of aluminium oxide have, on rare occasions been linked to cases of Toxic Anterior Segment Syndrome (TASS) in published literature. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Customers are advised to inspect their stock and quarantine all affected stock so that Designs For Vision Pty Ltd (distributor) can arrange for quarantined stock to be recovered and replacement stock, or a credit note, issued. Surgeons are advised that if a lens subject to this recall has been implanted, it is recommended that as a precaution, healthcare professionals monitor patients for up to one month post-operatively for symptoms of TASS, in case of late onset presentation. This action has been closed-out on 09/05/2017. |
| Contact Information |
1800 225 307 - Designs for Vision |