MAUDE Adverse Event Report: ACUFOCUS, INC. KAMRA; CORNEAL INLAY

Model Number	ACI 7000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Corneal Clouding/Hazing (1878); Visual Impairment (2138)
Date of Event	05/11/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
The reported information stated the inlay was explanted from the left eye of a (b)(6) female patient approximately five (5) months postoperatively due to corneal haze and blurred vision.
Additional Manufacturer Narrative
Concomitant medical product and therapy dates was confirmed to be asa and the date was corrected to (b)(6) 2015.The laser used in the pocket creation was added to the list.Relevant tests/laboratory data, including date: information was updated.
Event or Problem Description
It was reported by the clinic on (b)(6) 2016 that the patient's vision has not improved much and is still at 20/100.
Event or Problem Description
It was reported that the patient's vision has improved to 20/40 as of the first week of (b)(6) 2017.

• Brand Name: KAMRA
• Common Device Name: CORNEAL INLAY
• Manufacturer (Section D): ACUFOCUS, INC.; 32 discovery; suite 200; irvine CA 92618
• MDR Report Key: 5717244
• Report Number: 3008401069-2016-00009
• Device Sequence Number: 166599
• Product Code: LQE
• UDI-Device Identifier: 00813359020007
• UDI-Public: 00813359020007
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P120023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/27/2017
• Device Model Number: ACI 7000
• Device Catalogue Number: 76043
• Device Lot Number: A556-0515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/12/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 06/10/2016
• Supplement Report FDA Received Date: 07/13/2016; 12/07/2016; 02/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR