| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00477-1 |
| Product Name/Description |
SofPort Advanced Optics Aspheric IOL, Model LI61AO
LI61AO 13.00MM 22.5
Serial No.:4464602066
Expiry Date: 31-Aug-19
LI61AO 13.00MM 23.50
Serial No.: 4464642033
Expiry Date: 31-Aug-19
ARTG No: 98915 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/06/2015 |
| Responsible Entity |
|
| Reason/Issue |
An investigation was initiated based on a limited number of complaints received for broken haptics during lens loading and insertion. This investigation resulted in Bausch + Lomb determining that a portion of a batch of haptic material is performing differently than other batches in terms of material elongation properties. A broken haptic during lens loading and insertion can result in surgical intervention (lens exchange) and increase the chance of damaging the eye. There have not been any reports of the haptic breaking after the surgery is complete. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Customers are advised to segregate the affected IOLs and return them to their Bausch + Lomb (Australia) (B&L) representative. The B&L representative will arrange for the provision of replacement stock. If replacement product is needed for a scheduled surgery before the full return can be processed, please contact the B&L representative to expedite shipment of the IOL.
Surgeons are advised that if they have already implanted an affected IOL, there is no indication that the implanted IOL presents a health issue or performance concern. Therefore, patients should be followed as per their usual standard of care. All reports of broken haptics have occurred during lens loading or insertion. This could result in the need to exchange the lens during surgery. This action has been closed-out on 11/08/2016. |
| Contact Information |
02 8918 6322 Bausch & Lomb |