MAUDE Adverse Event Report: ACUFOCUS; KAMRA INLAY

Lot Number A-575-0715

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930); Corneal Infiltrates (2231)

Event Date 08/31/2016

Event Type  Injury  

Event Description

On (b)(6) 2016, pt had lasik both eyes with kamra inlay placed left eye same day.On (b)(6) 2016, pt presented with corneal infiltrate (hsv), possible inflammation / rejection of inlay placed on add'l meds.On (b)(6) 2016, sight threatening infection, corneal rejecting inlay, hsv still present, inlay removed/cultured, started pt on fortified vancomycin/amikacin/vigamox / polytrim, no growths noted on cultures.On (b)(6) 2016, new scraping gram stain, few negative rods, very few ecoli.On (b)(6) 2016, debulked necrotic corneal tissue left eye.On (b)(6) 2016, ambiodisk placed left eye.

• Type of Device: KAMRA INLAY
• Manufacturer (Section D): ACUFOCUS; irvine CA 92618
• MDR Report Key: 6063225
• MDR Text Key: 58813706
• Report Number: MW5065657
• 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: Nurse
• 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
• Device Operator: No Information
• Device Expiration Date: 07/31/2017
• Device Lot Number: A-575-0715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2016
• 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: 56 YR