AMO Puerto Rico Manufacturing recalls 361 TECNIS Eyhance IOL with TECNIS Simplicity Delivery System lenses sold nationwide through healthcare providers. The lenses may have a haptic that sticks to the optic, preventing unfolding as expected. Patients and clinicians should stop using the device immediately and follow recall instructions.
Due to identifying a limited quantity of intraocular lenses that may have a haptic that sticks to the optic which prevents the lens from unfolding as consistently as expected.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact AMO Puerto Rico Manufacturing, Inc. or your healthcare provider for instructions. Notification method: Letter
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TECNIS Eyhance IOL is a single-piece, foldable posterior chamber intraocular lens used in cataract surgery. The TECNIS SIMPLICITY Delivery System is designed to deliver the lens in a sterile, touch-free manner and preloads the lens for implantation.
A limited quantity of lenses may have a haptic that sticks to the optic, preventing unfolding as consistently as expected, which could impact proper lens placement.
This recall is not part of a broader industry pattern.
The recall affects patients who underwent cataract surgery using this specific IOL and delivery system. Clinicians must assess each case to determine whether replacement is necessary.
FDA recall page and your treating ophthalmologist.
Not specified in recall. Replacement or revision is determined by clinician guidance.
Keep recall notice, serial list, model number, clinician communications, and replacement plan.
Model/Catalog Number: DIB00. Software Version: N/A. Product: TECNIS Eyhance IOL with TECNIS Simplicity Delivery System. Distribution: U.S. nationwide in CA, FL, IL, ME, MS, NJ, NY, OK, OR, TX, WI. Quantity: 361. Sold through: healthcare providers. Lot/Serial numbers: Serial Numbers: 2409342403 2410072403 2409612403 2409692403 2409752403 2891682403 2891132403 2892032403 2531882403 2531902403 2531212403 2530842403 2531242403 2531892403 2531622403.
No injuries or incidents have been reported.
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