Reported Nov 5, 2014 · Terminated

ProClear Toric contact lenses are made from a material containing 62% water and 38% omafilcon B, a random copolymer of…

Cooper Vision Caribbean Corp.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Cooper Vision Caribbean Corp. · #500 Road 584 · Juana Diaz, PR · 00795

Is this the product you have?

  • ProClear Toric contact lenses are made from a material containing 62% water and 38% omafilcon B, a random copolymer of 2-hydroxyethylmethacrylate and methacrylic acid. The lenses have a tint (VAT Blue 6) which is added to make the lens more visible for handling.
Lot codes and dates
  • 246 of 246 codes

    • 10029500013022
    • 10029550001022
    • 10036550020022
    • 10055500013022
    • 10099500007022
    • 10106500024022
    • 10125500021022
    • 10169500001022
    • 10195550000022
    • 10423500014022
    • 10423550004022
    • 10424500021022
    • 10426500012022
    • 10427500014022
    • 10427500015022
    • 10427500016022
    • 10427500017022
    • 10427500018022
    • 10428500020022
    • 10428500021022
    • 10428500022022
    • 10428500023022
    • 10428500024022
    • 10428500025022
    • 10429500006022
    • 10429550000022
    • 10430500016022
    • 10430500017022
    • 10430500018022
    • 10430500019022
    • 10430500020022
    • 10019550013017
    • 10089500019017
    • 10089500020017
    • 10159500008017
    • 10229550003017
    • 10001500011008
    • 10001500012008
    • 10003550007008
    • 10003550008008
    • 10007500018008
    • 10007500019008
    • 10007550010008
    • 10008500014008
    • 10008500015008
    • 10010550020008
    • 10011500013008
    • 10011550013008
    • 10016550012008
    • 10024500018008
    • 10024550004008
    • 10037500023008
    • 10037550008008
    • 10043500019008
    • 10043500020008
    • 10044550009008
    • 10044550010008
    • 10045500015008
    • 10045500016008
    • 10046500024008
Amount recalled
13639 lenses/246 product lots

Where it was sold

  • Nationwide

Why it was recalled

Routine quality monitoring system has identified that a limited number of lots were manufactured with the cylinder axis outside the allowable specification.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 10, 2015 · Data as of Sep 19, 6:06 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.