MAUDE Adverse Event Report: ACUFOCUS ACUFOCUS; KAMRA INLAY

Lot Number A553-0415

Device Problem Insufficient Information (3190)

Patient Problems Corneal Abrasion (1789); Unspecified Infection (1930); Pain (1994); Visual Impairment (2138)

Event Date 08/17/2016

Event Type  Injury  

Event Description

Kamra inlay placed in right eye on (b)(6) 2016, pt presented with corneal abrasion/infection.On (b)(6) 2016, pt presented with worsening of pain infection, vision decreased placed on fortified tobramycin and vancomycin drops.On (b)(6) 2016 sight threatening infection, kamra inlay removed, cultures done, no growth on cultures.Pt went (on her own) to another doctor for second opinion/treatment.On (b)(6) 2016 info from the other physician shows their cultures revealing staph aureus, candida, enterobacter, strep agalactiae.

• Brand Name: ACUFOCUS
• Type of Device: KAMRA INLAY
• Manufacturer (Section D): ACUFOCUS; irvine CA 92658
• MDR Report Key: 6063224
• MDR Text Key: 58822521
• Report Number: MW5065656
• Device Sequence Number: 1
• Product Code: LQE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Lot Number: A553-0415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2016
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR