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	Intraocular Infection (1933)
Date of Event	05/26/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Inlay sent for culture by clinic.
Event or Problem Description
The reported information stated the inlay was explanted from the left eye of a (b)(6) male patient approximately three (3) months postoperatively due to an infection.
Event or Problem Description
Update: the patient responded to antibiotics but residual scarring is present.The patient is being treated with steroids to reduce scarring.The patient's vision is slowly improving and their bcva was reported to be 20/50 on (b)(6) 2016.
Event or Problem Description
Updated information: it was reported the patient condition remains the same; bcdva at 20/40 and no change in the appearance of the scar.

• Brand Name: KAMRA
• Common Device Name: CORNEAL INLAY
• Manufacturer (Section D): ACUFOCUS, INC.; 32 discovery; suite 200; irvine CA 92618
• MDR Report Key: 5717234
• Report Number: 3008401069-2016-00008
• Device Sequence Number: 16274286
• Product Code: LQE
• UDI-Device Identifier: 00813359020007
• UDI-Public: 00813359020007
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P1200023
• 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
• Report Date (Section B): 02/01/2017

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 Model Number: ACI 7000
• Device Catalogue Number: 76043
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/26/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 06/10/2016
• Supplement Report FDA Received Date: 11/18/2016; 02/01/2017
• 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: 63 YR