Reporter called to inform the fda that her implanted lenses in both right ((b)(6) 2013) and left ((b)(6) 2013) eyes have been recalled since 2014 and she was never informed of the recall.She learned about the recall today.To no avail, reporter stated that she informed the doctor immediately after being implanted that her vision was worse than what it was before, for both eyes.The implanted lenses have always given her problems with her vision but has escalated in the past year.Reporter stated that the recalled lenses are due to incorrect "raw material" used to manufacture the lenses and she would like to know more specifically what that entails and if it can cause loss of vision in the long term.Reference report: mw5151153.
|