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Recall Observatory FDA recall evidence

Device product

TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, STERILE.EO, Rx Only

Z-2288-2023

July 06, 2023

Class II

Product summary

Firm
Johnson & Johnson Surgical Vision, Inc.
Event
Event 92666
Status
Ongoing
Classification
Class II
Quantity
42
Official record key
device-enforcement:Z-2288-2023

Official wording

Reason: Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks.

Code information: 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,

Distribution pattern: International distribution to the countries of China, India, Korea.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks.