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 Clouding/Hazing (1878)
Date of Event	02/25/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was discarded by the user.
Event or Problem Description
The reported information stated the inlay was explanted from the right eye of a (b)(6) year old female patient approximately three (3) months and 20 days due to persistent corneal haze (pocket haze), blurred vision, and epithelial defect.Onset of the epithelial defect is unknown.On (b)(6) 2016, it was reported that the epithelial defect had closed.The corneal haze was treated with an extensive steroid regimen: durezol quid along with muro and alphagan to control intraocular pressure.It was noted during the (b)(6) 2016 visit, the haze was gone however, the patient developed a cataract due to the steroid regimen.Patient's vision has improved to a bcdva of 20/50 as reported on (b)(6) 2016.The patient has since undergone cataract surgery and the reported visual acuity is now 20/20.

• Brand Name: KAMRA
• Common Device Name: CORNEAL INLAY
• Manufacturer (Section D): ACUFOCUS, INC.; 32 discovery; suite 200; irvine CA 92618
• MDR Report Key: 6337824
• Report Number: 3008401069-2017-00001
• Device Sequence Number: 19108868
• 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: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/16/2017

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: 05/27/2017
• Device Model Number: ACI 7000
• Device Catalogue Number: 76043
• Device Lot Number: A556-0515
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2017
• Initial Report FDA Received Date: 02/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FEMTOSECOND LASER 1025-1-518; PHOTOREFRACTIVE KERATECTOMY (PRK)
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 58 YR