[xp84]

> For example: imagine you're driving and your whole field of vision suddenly starts flickering in and out of focus

Imagine you're driving with regular glasses and one tiny screw gives way and they fall off. Imagine you rub your eyes and your contact falls out. Those can't be 100% ruled out either.

But anyway, the FDA imposing a half decade of delays on this will do zero to prevent that from happening. The article says when unpowered they revert to being regular glasses for the main prescription. So the main reason they could glitch out like you suggest would be a software bug. After approval, a future software update could still introduce that bug anyway. So either the FDA has to find a way to review every software patch with perfect bug-detection abilities, or they are useless here and just wasting our money pretending to regulate things without adding any value.

Note that I'm not saying they have no role -- though I would say they do seem to be the worst in the first world at their actually needed job of balancing risk and access in the 'actual medications' department.