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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Keratitis (1944)

Event Date 09/12/2016

Event Type  Injury  

Manufacturer Narrative

Analysis cannot be performed.No lenses were returned for evaluation and lot number is unknown.The association between coopervision lenses and the event is unconfirmed.

Event Description

The contact lens worn by the patient induced keratitis.The patient was sleeping in contact lenses routinely.In the absence of medical information, this event is being reported out of abundance of caution.

• Brand Name: BIOFINITY SPHERE (COMFILCON A)
• Type of Device: BIOFINITY SPHERE (COMFILCON A)
• Manufacturer (Section D): COOPERVISION MANUFACTURING, LTD.; south point, hamble; unit 2; southampton, hampshire 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: 6052605
• MDR Text Key: 58244100
• Report Number: 9614392-2016-00028
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• 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: 10/10/2016

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
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/10/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other