| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01254-1 |
| Product Name/Description |
KAMRA Corneal Inlay (inserted into the natural cornea to treat presbyopia ie, age related hyperopia (far sightedness))
ARTG Number: 182104 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/12/2013 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer, AcuFocus is aware of reports of some cases involving use of ophthalmic laser applications in eyes containing KAMRA inlays. During laser treatment, the inlay may absorb the laser and produce heat. This may result in the inlay reducing in size and/or significant thermal damage. In some cases, there were secondary damage to the cornea resulting in scarring. As a result of these case reports, Ellex is providing additional warnings and information relative to the application of various ophthalmic procedures with a KAMRA inlay in situ. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The manufacturer has advised the inlays are not defective and function as intended. The purpose of this notification is to provide additional warnings and information with regard to further treatment to patients implanted with the KARMA inlay. |
| Contact Information |
08 8104 5226 - Ellex Regulatory Officer |