MAUDE Adverse Event Report: COOPERVISION MANUFACTURING, LTD. BIOFINITY MULTIFOCAL (COMFILCON A)

Device Problem Use of Device Problem (1670)

Patient Problem Acanthameba Keratitis (1945)

Event Type  Injury  

Event Description

The patient woke up with a scuff sensation in right (od) eye.Lenses are worn for an extended wear of time.The patient is diagnosed with keratitis and location is unknown.It is also unknown if medications were prescribed.This event is being reported in abundance of caution due to lack of medical information and unknown resolution.

• Brand Name: BIOFINITY MULTIFOCAL (COMFILCON A)
• Type of Device: BIOFINITY MULTIFOCAL (COMFILCON A)
• Manufacturer (Section D): COOPERVISION MANUFACTURING, LTD.; south point, hamble; unit 2; southampton, hampshire S031 4RF; UK S031 4RF
• Manufacturer (Section G): COOPERVISION MANUFACTURING LTD.; south point, hamble; unit 2; southampton, hampshire S031 4RF; UK S031 4RF
• Manufacturer Contact: ashley nguyen ; 5870 stoneridge drive; suite 1; pleasanton, CA 94588 ; 9256604414
• MDR Report Key: 6253769
• MDR Text Key: 64921199
• Report Number: 9614392-2017-00004
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P080011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/18/2016

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
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/18/2016
• Initial Date FDA Received: 01/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other