Reported Aug 9, 2023 · Ongoing
TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, STERILE.EO, Rx Only
Johnson & Johnson Surgical Vision, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Johnson & Johnson Surgical Vision, Inc. · 31 Technology Dr Ste 200 · Irvine, CA · 92618-2302
Is this the product you have?
- TECNIS Symfony, Extended Range of Vision IOL
- REFZXR00, STERILE.EO, Rx Only
- Lot codes and dates
- UDI-DI5050474579163/
- Serial Numbers
821014224482101522448210162244821017224482101822448210192244821020224482102122448210222244821023224482102422448210252244821026224482102722448210282244821029224482103022448210312244821032224482103322448210342244821035224482103622448210372244821038224482103922448210402244821041224482104222448210432244821044224482104522448210462244821047224482104822448210492244821050224482105122448210522244821053224482105422448210552244
- Amount recalled
- 42
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Why it was recalled
Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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