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 Codes	Foreign Body Sensation in Eye (1869); Blurred Vision (2137); Loss of Vision (2139); Visual Disturbances (2140)
Date of Event	06/01/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
The inlay was explanted approximately one (1) month postoperatively due to visual disturbances (blur, haze, and ghosting), foreign body sensation, and visual acuity impairment.As reported on 06/03/2016, the patient's vision has improved post explant.

• Brand Name: KAMRA
• Common Device Name: CORNEAL INLAY
• Manufacturer (Section D): ACUFOCUS, INC.; 32 discovery; suite 200; irvine CA 92618
• MDR Report Key: 5796963
• Report Number: 3008401069-2016-00012
• Device Sequence Number: 456760
• Product Code: LQE
• UDI-Device Identifier: 00813359020007
• UDI-Public: 00813359020007
• Combination Product (Y/N): N
• 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: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/14/2016

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 Model Number: ACI 7000
• Device Catalogue Number: 76043
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2016
• Initial Report FDA Received Date: 07/14/2016
• 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: 53 YR