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.
Check against the official notice below — it lists the full affected range.
Cooper Vision Caribbean Corp. is recalling ProClear Toric contact lenses due to a manufacturing defect identified through routine quality monitoring. A limited number of lens lots were manufactured with the cylinder axis outside allowable specifications. The affected lenses are made from a material containing 62% water and 38% omafilcon B. Approximately 13,639 lenses across 246 product lots are involved in this recall, with distribution worldwide including the United States nationwide and internationally to Canada, Latin America, European Union, Asia Pacific, and Africa/Central Eurasia countries.
The recall affects specific lot codes listed in the official record, which consumers can reference to determine if their product is affected. The source document does not specify what action affected consumers should take regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Routine quality monitoring system has identified that a limited number of lots were manufactured with the cylinder axis outside the allowable specification.
Reason for recall: Routine quality monitoring system has identified that a limited number of lots were manufactured with the cylinder axis outside the allowable specification. Distribution: Worldwide Distribution: US (nationwide) and internationally to: Canada, Latin America, EU, Asia Pacific, and Africa/Central Eurasia countries. Quantity: 13639 lenses/246 product lots Lot/code info: 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 10046550006008 10052500021008 10052550006008 10052550007008 10053550012008 10053550013008 10073500023008 10073500024008 10073500025008 10077500031008 10077500032008 10077500033008 10078500032008 10078500033008 10080550002008 10086500022008 10086500023008 10094500017008 10094500018008 10107500027008 10107500028008 10107550003008 10113500023008 10113500024008 10114500029008 10115500026008 10115500027008 10115550002008 10116500029008 10116500030008 10116550002008 10122500020008 10123500030008 10148550001008 10156500016008 10156550004008 10183550000008 10183550001008 10184500006008 10185500007008
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.