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Recall Observatory FDA recall evidence

Device product

Alden HP49 Toric Daily Wear Soft contact; Catalog Number: AOHPT49 Product Usage: The ALDEN TORIC LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia) and/or possesses refractive astigmatism not exceeding 10 Diopters.

Z-0987-2018

November 03, 2017

Class II

Product summary

Firm
Alden Optical
Event
Event 79377
Status
Terminated
Classification
Class II
Quantity
56
Official record key
device-enforcement:Z-0987-2018

Official wording

Reason: Contact lenses lack sterility assurance.

Code information: AZ150010 AZ150020 AZ126720 AZ153710 AZ153720 AZ136110 AZ146910 AZ146920 AZ143710 AZ143720 AZ146610 AZ146620 AZ156210 AZ156220 AZ151510 AZ155210 AZ138410 AZ138420 AZ154810 AZ154620 AZ162310 AZ162320 AZ159810 AZ159820 AZ145220 AZ151120

Distribution pattern: Worldwide Distribution - US Nationwide in the states:of CA, FL, GA, ID, IL, IN, KS, KY, MD, MI, MO, MS, NC, NJ, NM, NV, NY, OH, OR, PA, TX, VA, WI, WY and the country of Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Contact lenses lack sterility assurance.