Z-1235-2016Class II

KAMRA Inlay, ACI 7000 Corneal Inlay, Part No. 76195-01 and 76195-10 (OUS) Labeling: The KAMRA inlay is...

Name: Z-1235-2016 KAMRA Inlay, ACI 7000 Corneal Inlay, Part No. 76195-01 and 76195-10 (OUS) Labeling: The KAMRA inlay is...
Creator: AcuFocus, Inc.
Published: 2016-02-11
License: https://open.fda.gov/license/

AcuFocus, Inc. / initiated 2016-02-11 / Terminated / root cause: labeling and UDI

FDA source

AcuFocus, Inc. began a recall of 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... on 2016-02-11. FDA classified it as Class II and gives the reason as "AcuFocus is recalling KAMRA ACI 7000 Corneal Inlays due to concerns with the labeled shelf life". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1235-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-11
Posted: 2016-03-24
Terminated: 2016-05-04
Recalling firm: AcuFocus, Inc.
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.
Product code: LQE Implant, Corneal, Refractive
Reason for recall: AcuFocus is recalling KAMRA ACI 7000 Corneal Inlays due to concerns with the labeled shelf life.
Root cause tag: labeling and UDI
FDA root cause: 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: [email protected], 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.
Product codes and lots: Lots A534-1014 and A535-1014

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1235-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1235-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-30	2016-03-24

Product code LQE

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)