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 Code	Corneal Clouding/Hazing (1878)
Date of Event	07/28/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
The reported information stated the inlay was explanted from the right eye of a (b)(6) year old male patient approximately 21 days postoperatively due to corneal haze.
Additional Manufacturer Narrative
An attempt to submit this follow-up report occurred on 10/18/2016 however, a duplicate report error was received.The duplicate report error has since been corrected and the report is being re-submitted.Please disregard the information provided in follow-up report #1 as it was not associated with this event.Initial report was updated to the individual who provided the follow-up information.

• Brand Name: KAMRA
• Common Device Name: CORNEAL INLAY
• Manufacturer (Section D): ACUFOCUS, INC.; 32 discovery; suite 200; irvine CA 92618
• MDR Report Key: 5799220
• Report Number: 3008401069-2016-00016
• Device Sequence Number: 916009
• 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: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/02/2016

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: A555-0515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/01/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 07/15/2016
• Supplement Report FDA Received Date: 07/15/2016; 12/02/2016
• 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: 52 YR