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Recall Observatory FDA recall evidence

Device product

Alcon PRECISION1 One-Day Contact Lenses, -2.25D.

Z-0326-2026

September 30, 2025

Class II

Product summary

Firm
Alcon Research LLC
Event
Event 97739
Status
Ongoing
Classification
Class II
Quantity
82 units
Official record key
device-enforcement:Z-0326-2026

Official wording

Reason: Potential for a weak seal in some units resulting in compromise in sterility.

Code information: GTIN: 00730822254946; Lot Number: A8041128

Distribution pattern: Worldwide - US distribution in the states of Alabama, Arizona, Arkansas, Connecticut, Florida, Idaho, Iowa, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, New Jersey, New York, Oklahoma, Oregon, Tennessee, Texas, Washington and the country of Canada.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    weak seal
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    seal in some units resulting in compromise in sterility