FDA Device recall Z-0134-2015
ProClear Toric contact lenses are made from a material containing 62% water and 38% omafilcon B, a random copolymer of 2-hydroxyethylmethac…
- FDA Device
- Class III
- terminated
- Published 2014-11-05
On 2014-11-05 the FDA classified a Class III recall of ProClear Toric contact lenses are made from a material containing 62% water and 38% omafilcon B, a random copolymer of 2-hydroxyethylmethac… by Cooper Vision Caribbean, citing routine quality monitoring system has identified that a limited number of lots were manufactured with the cylinder axis outside the allowable specification.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0134-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-09-17 |
| Published | 2014-11-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Cooper Vision Caribbean |
| Distribution | US |
Product
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.
Reason
Routine quality monitoring system has identified that a limited number of lots were manufactured with the cylinder axis outside the allowable specification.
Identifiers
| code_info | 10029500013022 10029550001022 10036550020022 10055500013022 10099500007022 10106500024022 10125500021022 1016950…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 10052550 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0134-2015%22
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