MAUDE Adverse Event Report: ACUFOCUS ACUFOCUS, KAMRA INLAY

Lot Number A553-0415

Device Problem Insufficient Information (3190)

Patient Problems Abrasion (1689); Red Eye(s) (2038); Blurred Vision (2137); Viral Infection (2248)

Event Date 07/08/2016

Event Type  Injury  

Event Description

Pt had kamra inlay placed in the left eye (b)(6) 2016, pt presented with red, burning, watering eye, abrasion noted, bandage contact lens placed.Pt returned (b)(6) 2016 with haze over the inlay and abrasion.Not sure if eye rejecting inlay.Inlay removed from cornea, cultured.Placed pt on fortified vancomycin and tobramycin, seen on (b)(6) 2016 with herpes simplex keratitis involvement also, placed pt on acyclovir oral med, sight-threatening infection.

• Brand Name: ACUFOCUS, KAMRA INLAY
• Type of Device: KAMRA INLAY
• Manufacturer (Section D): ACUFOCUS; irvine CA 92618
• MDR Report Key: 6056665
• MDR Text Key: 58381299
• Report Number: MW5065597
• 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: 10/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2016
• Is this an Adverse Event Report?: Yes
• 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: 08/30/2016
• 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: 52 YR