Z-0529-2015Class II

Soft Contact Lens

Name: Z-0529-2015 Soft Contact Lens
Creator: Cooper Vision Caribbean Corp.
Published: 2014-10-28
License: https://open.fda.gov/license/

COOPERVISION Manufacturing Puerto Rico, LLC / initiated 2014-10-28 / Terminated / root cause: manufacturing process

FDA source

Cooper Vision Caribbean Corp. began a recall of Soft Contact Lens on 2014-10-28. FDA classified it as Class II and gives the reason as "Portions of the lots may contain units with an incorrect lens axis condition". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0529-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-28
Posted: 2014-12-15
Terminated: 2015-10-02
Recalling firm: COOPERVISION Manufacturing Puerto Rico, LLC
Product: Soft Contact Lens
Product code: LPM Lenses, Soft Contact, Extended Wear
Reason for recall: Portions of the lots may contain units with an incorrect lens axis condition.
Root cause tag: manufacturing process
FDA 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 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.
Product codes and lots: Lots # 8246525202 & 8255525096

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0529-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0529-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-09

Product code LPM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)