FDA recall Z-0983-2018

Alden Optical · Class II · device

Product

Alden Classic 38 Sphere Daily Wear Soft contact; Catalog Number: AOCLS38 Product Usage: The ALDEN SPHERE 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). The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity.

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-0983-2018