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U.S. Department of Health and Human Services

Class 2 Device Recall Biomedics Toric

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  Class 2 Device Recall Biomedics Toric see related information
Date Initiated by Firm October 28, 2014
Date Posted December 15, 2014
Recall Status1 Terminated 3 on October 02, 2015
Recall Number Z-0529-2015
Recall Event ID 69496
PMA Number P890023 
Product Classification Lenses, soft contact, extended wear - Product Code LPM
Product Soft Contact Lens
Code Information Lots # 8246525202 & 8255525096 
Recalling Firm/
Manufacturer		 Cooper Vision Caribbean Corp.
500 Road 584
Amuelas Industrial Park
Juana Diaz PR 00795
Manufacturer Reason
for Recall		 Portions of the lots may contain units with an incorrect lens axis condition.
FDA Determined
Cause 2		 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 impairment. There is currently no indication that use of a lens with an Off Axis condition will create an injury requiring medical intervention. No permanent impairment is anticipated with or without medical intervention. Based on the analysis " described in the attached Health Hazard Evaluation, CooperVision will initiate a Class Ill recall. As noted by regulation, this classification is consistent with a situation in which use of, or exposure to, the product is unlikely .to cause adverse health consequences. Our evaluation of the Off Axis condition indicates it is unlikely to cause an adverse health reaction. Based on a Class Ill determination, the recall shall be conducted to the Wholesale level with a planned Effectiveness Check at Level B - 50% of Consignees to be contacted. Public Warning- in light of the low risk and proposed recall classification; a public warning is not warranted at this time. Distribution includes: " North America: Canada, USA " Latin America: Argentina, Brasil, Chile, Colombia, Ecuador, Guatemala, Uruguay, Venezuela, Mexico " Europe: Belgium, Denmark, Germany, France, Netherlands, Poland, Spain, Sweden, Switzerland " Australia Returned lenses will be quarantined from distribution and destroyed as required. Actions and Dates: " Notify FDA through 806 Form on 10/23/14 " Initiate External communications starting 10/28/2014 " C
Quantity in Commerce 1170
Distribution US Nationwide Distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = LPM and Original Applicant = THE COOPER COMPANIES
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