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

Model Number	ACI 7000
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Corneal Infiltrates (2231)
Date of Event	09/15/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
The reported information stated the inlay was explanted from a female patient due to an infiltrate adjacent to the inlay.

• Brand Name: KAMRA
• Common Device Name: CORNEAL INLAY
• Manufacturer (Section D): ACUFOCUS, INC.; 32 discovery; suite 200; irvine CA 92618
• MDR Report Key: 6946270
• Report Number: 3008401069-2017-00010
• Device Sequence Number: 19003655
• Product Code: LQE
• UDI-Device Identifier: 00813359020052
• UDI-Public: 00813359020052
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P120023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/12/2017

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: 01/27/2018
• Device Model Number: ACI 7000
• Device Catalogue Number: 76225
• Device Lot Number: A599-0116
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2017
• Initial Report FDA Received Date: 10/12/2017
• 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: 44 YR