SOFT CONTACT LENSES (toric) packaged under the following labels: (1) CV \ ENCORE toric (methafilcon A) and (2) ONEVUE 55 toric (methafilcon A) flexible wear. Responsible firm on label: Coopervision, Hamble, SO31, 4RF, UK, Scottsville, NY 14546, USA *** Made in UK. The lenses are sold in boxes of 6 and sold individually as trial lenses.
FDA Recall Z-0978-03 · Posted 2003-07-03
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Recalling FirmCoopervision Inc
Recall StatusTerminated
Product CodeLPL
Date Initiated2003-06-25
Date Terminated2005-04-11
Product Quantity23,762 6-packs / 76,748 singles (trial lenses)
Reason for Recall
The actual sphere power of the lens is lower than the labeled value.
Firm Action
Letters dated June 24, 2003 issued to eye care practitioners and distributors with instructions to return lenses to Coopervision. Distributors also instructed to notify their customers.
Root Cause
Other
Distribution Pattern
Coopervision, Scottsville, NY is recalling from domestic customers nationwide. Product in Canada and Europe being recalled by affiliate in Europe.
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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