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U.S. Department of Health and Human Services

Class 2 Device Recall KAMRA INLAY

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  Class 2 Device Recall KAMRA INLAY see related information
Date Initiated by Firm February 11, 2016
Create Date March 24, 2016
Recall Status1 Terminated 3 on May 04, 2016
Recall Number Z-1235-2016
Recall Event ID 73343
PMA Number P120023 
Product Classification Implant, corneal, refractive - Product Code LQE
Product KAMRA Inlay, ACI 7000 Corneal Inlay, Part No. 76195-01 and 76195-10

(OUS) Labeling: The KAMRA inlay is indicated for the improvement of near visual acuity in one eye (usually the non-dominant eye) of a presbyopic patient.

Code Information Lots A534-1014 and A535-1014
Recalling Firm/
AcuFocus, Inc.
32 Discovery Ste 200
Irvine CA 92618-3161
For Additional Information Contact
949-585-9511 Ext. 106
Manufacturer Reason
for Recall
AcuFocus is recalling KAMRA ACI 7000 Corneal Inlays due to concerns with the labeled shelf life.
FDA Determined
Cause 2
Under Investigation by firm
Action The firm, AcuFocus, sent an "URGENT FIELD SAFETY NOTICE" letter dated 2/11/16 to all their customers to inform them that AcuFocus is recalling 2 lots of KAMRA ACI 7000 Corneal Inlays due to concerns with the labeled shelf life. The described the product, problem and the actions to be taken. Customers are instructed to report any abnormal appearance of the implanted KAMRA inlay to AcuFocus, inc; stop using and remove from your inventory all affected lots; complete and return the attached Customer Recall Response Form via email: customerservice@acufocus.com, Fax: +1 (949) 585-9545 Attn: Recall Coordinator, or mail to: AcuFocus Inc., Attn: Recall Coordinator, 32 Discovery, Suite 200, Irvine CA 92618, within 3 business days even if you have no inventory affected by this recall; and provide the attached Customer Field Safety Notice and Customer Recall Response Form to your customers who have or may have received product from the affected two lots. Customers with product complaint events are instructed to report regarding KAMRA inlays involved in this recall event, and to inform AcuFocus, Inc. by calling +1 (949) 585-9511 ext 608. Customers with any questions related to the return process, are instructed to contact an AcuFocus Customer Service Representative at +1 (949) 585-9511 ext 608.
Quantity in Commerce 182 units
Distribution International distribution in countries of: Canada, Germany, Saudi Arabia, Turkey, and United Kingdom.
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 = LQE and Original Applicant = CorneaGen