| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01194-1 |
| Product Name/Description |
Lentis Foldable Intraocular Lenses (IOL)
Model Numbers starting with L-, LU- and LS-
Expiry: between 2017-01 and 2020-05
ARTG Number: 198807 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/09/2017 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer Oculentis has identified possible sporadic opacification of the Intraocular Lens (IOL). Studies conducted for Oculentis have indicated that surface calcification could possibly be the result of phosphate remnants originating from a detergent previously used in the cleaning process of the IOL. Although the cause of IOL opacification is multifactorial, remnants could make the IOL under certain conditions more prone to opacification.
The opacification may compromise the optical transparency of the IOL in time, potentially leading to a slow reduction in the patient's visual acuity. |
| Recall Action |
Recall |
| Recall Action Instructions |
1. For on-shelf units, users are to quarantine all affected stock, then complete and return the attached reply form fax to acknowledge receipt of this notice and advise your quantity of affected stock.
2. For implanted units there is no need for explanting or review of patients where the lens has been implanted.
3. In some cases, postoperative opacification of the IOL may present biomicroscopic aspects similar to posterior capsule opacification. Practitioners are advised to carefully evaluate each case to determine the exact nature of the cloudiness.
4. IOL exchange is the only recommended treatment for postoperative opacification if the visual acuity is compromised in view of the patient's individual conditions and needs.
This action has been closed out on the 24/09/2018. |
| Contact Information |
02 8244 3816 - Device Technologies |