Device product
Alden HP54 Toric Daily Wear Soft contact; Catalog Number: AOHPT54 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-0988-2018
Product summary
- Firm
- Alden Optical
- Event
- Event 79377
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14
- Official record key
device-enforcement:Z-0988-2018
Official wording
Reason: Contact lenses lack sterility assurance.
Code information: AZ150620 AZ159220 AZ156710 AZ156720
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
Contact lenses lack sterility assurance.