AMO Puerto Rico Manufacturing, Inc. is recalling 361 units of the TECNIS Eyhance IOL with TECNIS Simplicity Delivery System. A manufacturing defect may cause the lens's haptic (the small arm that holds the lens in place) to stick to the optic, preventing the lens from unfolding properly once inside the eye. If you have been scheduled for or recently underwent surgery with this specific model, contact your surgeon or healthcare provider.
A haptic that sticks to the lens optic prevents the intraocular lens from unfolding as consistently as expected during surgery. This can lead to improper lens positioning or surgical complications that may require additional medical intervention.
SKU: DIB00U0210-12. The delivery system contains the TECNIS Eyhance IOL, a one-piece, foldable, posterior chamber lens.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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