Frequency 55 Toric (methafilcon B), flexible wear contact lenses (tinted). Responsible firms on the label: CooperVision ** Hamble, SO31 4RF, UK ** Scottsville, NY 14546.
FDA Recall Z-1091-03 · Posted 2003-08-07
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Recalling FirmCoopervision Inc
Recall StatusTerminated
Product CodeLPL
Date Initiated2003-07-22
Date Terminated2004-02-13
Product Quantity152 lenses
Reason for Recall
Mislabeled with incorrect sphere power.
Firm Action
Customers notified via telephone on 7/22/03.
Root Cause
Other
Distribution Pattern
Nationwide. 33 eye care practitioners in the following states: AR, AL, CA, DE, FL, GA, IA, KS, MI, MA, NJ, NY, NC, OH, OK, PA, TX, UT, VA, and WI. Lenses were also shipped to Coopervision affiliates in the United Kingdom and Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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