TECNIS Eyhance intraocular lens haptic may stick to the optic
AMO Puerto Rico Manufacturing is recalling TECNIS Eyhance IOLs with the TECNIS Simplicity Delivery System because a limited quantity may have a haptic that sticks to the optic, preventing consistent unfolding.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: a lens that does not unfold consistently during implantation is a hazard during surgery, and no injuries are stated.
Plain-English summary
AMO Puerto Rico Manufacturing, Inc. is recalling the TECNIS Eyhance IOL with TECNIS Simplicity Delivery System, model DIB00. The delivery system provides a sterile, controlled and touch-free method of delivering the preloaded one-piece foldable posterior chamber lens into the eye. About 361 units were distributed across eleven US states. The FDA has classified this recall as Class II.
A limited quantity of intraocular lenses were identified that may have a haptic that sticks to the optic, which prevents the lens from unfolding as consistently as expected.
Affected product carries GTIN 05050474731776 and SKU DIB00U0210-12, across fifteen listed serial numbers.
Facilities can identify affected lenses by the model number, GTIN and serial numbers above, and may contact AMO Puerto Rico Manufacturing, Inc. for further information.
The recalled product
- Product
- Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Model/Catalog Number: DIB00 Software Version: N/A Product Description: The TECNIS SIMPLICITY" Delivery System is designed to…
- Manufacturer
- AMO Puerto Rico Manufacturing, Inc.
- Affected units
- 361
Distribution
Related recalls
Same manufacturer · AMO Puerto Rico Manufacturing, Inc.
See all →- ModerateAMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Labeling
FDA (Devices) · 2014-08-27
- ModerateAMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Labeling
FDA (Devices) · 2014-08-27
- ModerateAMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Labeling
FDA (Devices) · 2014-08-27
- ModerateAMO Tecnis CL Intraocular Lenses Recalled for Incorrect Diopter Labeling
FDA (Devices) · 2014-08-27
- ModerateAMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Power Labeling
FDA (Devices) · 2014-08-27
Similar recalls
- HighFDA Recalls TECNIS Eyhance Intraocular Lenses for Elevated Endotoxin
FDA (Devices) · 2021-10-13
- HighIntraocular Lenses Recalled Due to Unintended Fiducial Marks
FDA (Devices) · 2023-08-09
- ModerateAMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Labeling
FDA (Devices) · 2014-08-27
- ModerateAbbott Recalls TECNIS Intraocular Lenses Due to Mislabeled Units
FDA (Devices) · 2016-09-28
- ModerateAMO TECNIS CL Foldable Silicone IOLs Recalled for Incorrect Diopter Labeling
FDA (Devices) · 2014-08-27
- ModerateAMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Power Labeling
FDA (Devices) · 2014-08-27