Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 17876 |
| Brand Name: | Oculentis LENTIS HydroSmart foldable intraocular lens |
| Model: | All IOL models starting with L-, LU-, or LS- |
| Affected: | Serial numbers starting with 20000 |
| Software version: | |
| Recalling Organisation: | Device Technologies New Zealand 47 Arrenway Drive Albany AUCKLAND 0632 |
| Contact Information: | 09 913 2000 |
| Manufacturer: | Oculentis GmbH |
| Issue: | Oculentis GmbH has received sporadic notifications of postoperative opacification of the LENTIS® Hydrosmart IOLs in glass vials, resulting in a reported occurrence rate of 0.011% of all implanted Hydrosmart IOLs 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 IOLs. 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 type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 24/12/2014 |
