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
100295000130221002955000102210036550020022100555000130221009950000702210106500024022101255000210221016950000102210195550000022104235000140221042355000402210424500021022104265000120221042750001402210427500015022104275000160221042750001702210427500018022104285000200221042850002102210428500022022104285000230221042850002402210428500025022104295000060221042955000002210430500016022104305000170221043050001802210430500019022104305000200221001955001301710089500019017100895000200171015950000801710229550003017100015000110081000150001200810003550007008100035500080081000750001800810007500019008100075500100081000850001400810008500015008100105500200081001150001300810011550013008100165500120081002450001800810024550004008100375000230081003755000800810043500019008100435000200081004455000900810044550010008100455000150081004550001600810046500024008
- 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.
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