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 Infiltrates (2231)
Date of Event	06/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Patient presented with sub-epithelial sterile infiltrates and complaints of photophobia in the right eye, five weeks postoperatively.
Additional Manufacturer Narrative
Updated patient's progress was added to relevant tests/lab data.Device lot number and expiration date were retrieved and added to mfr name, city, and state.Type of report updated to followup 1 in type of reports.Event and problem and evaluation codes were updated as follows: (b)(4).
Event or Problem Description
Update: patient was last seen on (b)(6) 2016.It was reported that the vision in the kamra inlay eye was 20/30, patient is happy with vision, and a faint sub-epithelial haze superiorly remains.
Event or Problem Description
Update: the patient was last seen in (b)(6) by dr.(b)(6) at (b)(6) who reported the patient had a corneal melt on the inlay eye and had consequently removed the inlay.Additionally, the patient's vision has recovered post removal and no infection was noted.

• Brand Name: KAMRA
• Common Device Name: CORNEAL INLAY
• Manufacturer (Section D): ACUFOCUS, INC.; 32 discovery; suite 200; irvine CA 92618
• MDR Report Key: 5799217
• Report Number: 3008401069-2016-00013
• Device Sequence Number: 628848
• Product Code: LQE
• UDI-Device Identifier: 00813359020007
• UDI-Public: 00813359020007
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/27/2017
• Device Model Number: ACI 7000
• Device Catalogue Number: 76043
• Device Lot Number: A569-0715
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/21/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 07/15/2016
• Supplement Report FDA Received Date: 08/19/2016; 10/18/2016; 12/08/2016
• 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