FDA recall Z-0989-2018

Alden Optical · Class II · device

Product

Alden Classic 55 Toric Daily Wear Soft contact; Catalog Number: AOCLT55 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.

Reason for recall

Contact lenses lack sterility assurance.

Distribution

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.

Key facts

Status
Terminated
Initiation date
2017-11-03
Report date
2018-03-21
Termination date
2018-06-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lancaster, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0989-2018