Neulook Deluxe is packaged in a pink soft plastic box with white, black, and rainbow printing that reads, NeuLook COLOR

FDA device recall Z-0643-2012 · posted 2012-01-11 · Terminated

Recall details

Recalling firm

Eyezone

Reason for recall

This recall has been initiated because Pishon Trading dba Eyezone have distributed soft color lens while on FDA hold and were later found to be misbranded.

Action taken

Pishon Trading sent an Urgent Medical Device Recall letter dated November 9, 2011, to all affected customers. The letter provided the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to examine their inventory and quarantine the recalled product, and they were instructed to return the recalled products to Pishon Trading. Customers were instructed to complete and return the enclosed response form as soon as possible. If customers had any questions, they can call (562) 906-1100. On December 16, 2011, Pishon Trading expanded their recall by sending a new recall letter to all their customers who purchased the Neulook Deluxe and Neulook Fancy contact lens to include all lots.

Root cause

Labeling False and Misleading

Status

Terminated

Product code

LPL

Quantity affected

24,628 total pairs

Distribution

Nationwide Distribution including LA, MS, NV, CA, TX, TN, AR, HI, IL, GA, and FL..

Date initiated

2011-12-05

Date posted

2012-01-11

Date terminated

2014-09-04

Location

Santa Fe Springs, CA

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