CLASS II ONGOING Device recall · Reported 9 Aug 2023 · FDA Enforcement Report
Tecnis Symfony, Extended Range of Vision IOL recalled
Johnson & Johnson Surgical Vision is recalling Tecnis Symfony, Extended Range of Vision IOL. The recall was initiated on 6 Jul 2023 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-2288-2023
- FDA event ID
- 92666
- Recalling firm
- Johnson & Johnson Surgical Vision, Irvine, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 6 Jul 2023
- FDA classified
- 3 Aug 2023
- Reported
- 9 Aug 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Contact Lenses & Eye Devices
Timeline
| 6 Jul 2023 | Recall initiated by company | |
| 3 Aug 2023 | Classified by FDA | +28 days |
| 9 Aug 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks.
Product as listed by the FDA
TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, STERILE.EO, Rx Only
Where it was distributed
International distribution to the countries of China, India, Korea.
Questions about this recall
Why was it recalled?
Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks.
Which lots are affected?
UDI-DI: 5050474579163/ Serial Numbers: 8210142244, 8210152244, 8210162244, 8210172244, 8210182244, 8210192244, 8210202244, 8210212244, 8210222244, 8210232244, 8210242244, 8210252244, 8210262244, 8210272244, 8210282244, 8210292244, 8210302244, 8210312244, 8210322244, 8210332244, 8210342244, 8210352244, 8210362244, 8210372244, 8210382244, 8210392244, 8210402244, 8210412244, 8210422244, 8210432244, 8210442244, 8210452244, 8210462244, 8210472244, 8210482244, 8210492244, 8210502244, 8210512244, 8210522244, 8210532244, 8210542244, 8210552244,
Where was it sold?
International distribution to the countries of China, India, Korea.
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.
Other products in this recall event
1 other product · FDA event 92666| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Tecnis Eyhance IOL recalled by Johnson & Johnson Surgical | Johnson & Johnson Surgical Vision | Other | CA |
More recalls from Johnson & Johnson Surgical Vision
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|---|---|---|---|---|---|
| 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 | Veritas Advanced Infusion Packs (Vrt-ai) recalled | Johnson & Johnson Surgical Vision | Device Malfunction | Nationwide |
Other Contact Lenses & Eye Devices recalls
All 153| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Pearle Vision 1 day (somofilcon A) Contact Lens recalled by CooperVision | CooperVision | Other | Nationwide |
| 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 |