CLASS II Device recall · Reported 13 Oct 2021 · FDA Enforcement Report
Tecnis Eyhance IOLs are permanent intraocular implants recalled
Johnson & Johnson Surgical Vision is recalling Tecnis Eyhance IOLs are permanent intraocular implants intended for implantation in the, distributed nationwide in the US. The recall was initiated on 6 Aug 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0028-2022
- FDA event ID
- 88564
- Recalling firm
- Johnson & Johnson Surgical Vision, Santa Ana, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Aug 2021
- FDA classified
- 4 Oct 2021
- Reported
- 13 Oct 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Contact Lenses & Eye Devices
Timeline
| 6 Aug 2021 | Recall initiated by company | |
| 4 Oct 2021 | Classified by FDA | +59 days |
| 13 Oct 2021 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Nonconforming product was distributed in error. Product was nonconforming due endotoxin levels higher than both the Firm's internal endotoxin specification limit and the FDA recommended endotoxin specification limit. Product was released in error based on the results of additional testing performed during the investigation into release testing nonconformance.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
TECNIS Eyhance IOLs are permanent intraocular implants intended for implantation in the capsular bag. The TECNIS Simplicity Delivery System is designed as a single-use disposable preloaded modular cartridge that functions as both the primary packaging and as a sterile, disposable insertion system for delivering the IOL into the eye during cataract surgery.
Where it was distributed
U.S. Nationwide distribution in the state of IL.
Questions about this recall
Why was it recalled?
Nonconforming product was distributed in error. Product was nonconforming due endotoxin levels higher than both the Firm's internal endotoxin specification limit and the FDA recommended endotoxin specification limit. Product was released in error based on the results of additional testing performed during the investigation into release testing nonconformance.
Which lots are affected?
Model: DIU225U050 UDI Code: (01)05050474745831(17)240414(21)5248142104 Production Order Number: 900001985625 Serial Number: 5248142104
Where was it sold?
U.S. Nationwide distribution in the state of IL.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Johnson & Johnson Surgical Vision
All 18| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Healon EndoCoat PRO recalled by Johnson & Johnson Surgical | Johnson & Johnson Surgical Vision | Other | Nationwide |
| Device | CLASS II | Johnson & Johnson Vision Reusable Laminar High Flow recalled | Johnson & Johnson Surgical Vision | Other | Nationwide |
| Device | CLASS II | Tecnis Toric II OptiBlue IOL recalled by Johnson & Johnson Surgical | Johnson & Johnson Surgical Vision | Potency & Assay | CA |
| Device | CLASS II | Tecnis Eyhance IOL recalled by Johnson & Johnson Surgical | Johnson & Johnson Surgical Vision | Other | CA |
| Device | CLASS II | Tecnis Symfony, Extended Range of Vision IOL recalled | Johnson & Johnson Surgical Vision | Other | CA |
Other Contact Lenses & Eye Devices recalls
All 152| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Tecnis Eyhance Iol with Tecnis Simplicity" Delivery System recalled | AMO Puerto Rico Manufacturing | Device Malfunction | Nationwide |
| Device | CLASS II | Alcon PRECISION1 One-Day Contact Lenses, -2.25D recalled | Alcon Research | Sterility | 19 states |
| Device | CLASS II | Sofmed Breathables, (stenfilcon A) contact lens recalled by CooperVision | CooperVision | Sterility | Nationwide |
| Device | CLASS II | Voyant 1-Day Premium Toric, (stenfilcon A) contact lens recalled | CooperVision | Sterility | Nationwide |
| Device | CLASS II | MyDay Toric, stenfilcon A) Contact Lens recalled by CooperVision | CooperVision | Sterility | Nationwide |