Recall Z-0529-2015 ยท LPM Lenses, Soft Contact, Extended Wear
Cooper Vision Caribbean Corp.
Soft Contact Lens
| Date | Dec 15, 2014 (initiated Oct 28, 2014) |
| Status | Terminated |
| Reason | Portions of the lots may contain units with an incorrect lens axis condition. |
| Root cause | Process control |
| Action | This recall is being initiated to the wholesale/distributor and Eye Care Practitioner level. Written communications will be forwarded to all first level consignees by overnight mailin..9. Receipt" tracking and follow up with consignees will be conducted according to the Effectiveness Check noted below. . - . The 0ff Axis condition is ~onsistent with a situation in which use of, or exposure to, the product is unlikely to cause adverse health consequences. A user may notice blurred vision due to the axis being out of specification but removal of the lens effectively reduces/eliminates any impair |
| Quantity | 1170 |
| Distribution | US Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.