| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01322-1 |
| Product Name/Description |
LENTIS HydroSmart Foldable Intraocular Lenses in Glass Vials
IOL Model Numbers: All starting with L-, LU-, or LS-
Serial Numbers: All starting with 20000
ARTG Number: 192478
(All Oculentis IOL models packaged in a blister are not affected by this recall action.) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/12/2014 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has received sporadic notifications of postoperative opacification of the LENTIS Hydrosmart Inta Ocular Lenses (IOL’s) in glass vials of all implanted Hydrosmart IOL’s since 2006.
Analysis suggests a possible interaction between phosphate crystals originating from the hydration process of the IOL material and the fluctuating, batch related presence of silicone residues on some IOL’s. Such residues may potentially change the IOL surface properties, making it under certain medical conditions more prone to deposition of calcium phosphate from the aqueous humor in predisposed patients. These deposits may compromise the optical transparency of the IOL, potentially leading to a reduction in the patient’s visual acuity. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Customers are requested to inspect their stock and quarantine any affected units in preparation for return to Device Technologies.
Surgeons are advised that if postoperative opacification is observed to evaluate visual acuity levels and consider surgical IOL replacement if visual acuity is compromised in face of the patient’s individual conditions and needs. Intraocular lens replacement is the only recommended treatment for postoperative calcification of the IOL leading to compromise of visual acuity. In some cases postoperative opacification of the IOL may present bio- microscopic aspects similar to posterior capsule opacification. Practitioners are advised to carefully evaluate each case to determine the exact nature of the cloudiness and avoid YAG laser capsulotomy in patients with an opacificied IOL since this procedure may affect the IOL replacement if needed in the future.
Please see http://www.tga.gov.au/alert/lentis-hydrosmart-intraocular-lenses-supplied-glass-vials .
This action has been closed-out on 4/08/2016. |
| Contact Information |
02 9975 5755 - Device Technologies Australia |