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

Lot Number 10589000030000

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Corneal Edema (1791); Inflammation (1932); Keratitis (1944)

Event Date 06/04/2016

Event Type  Injury  

Event Description

It was reported by a business partner that a consumer unknowingly wore two contact lenses simultaneously in each eye for two days.The consumer developed symptoms when they did not remove the second lens from eye (od).Medical treatment was sought and the consumer was diagnosed with acute corneal edema/keratitis and conjunctival inflammation.Referred to an eye hospital, the consumer's symptoms have resolved after topical treatment.

• 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: alex jordan ; 5870 stoneridge drive; suite 1; pleasanton, CA 94588 ; 9256213782
• MDR Report Key: 5800463
• MDR Text Key: 49756266
• Report Number: 9614392-2016-00020
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P080011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 10589000030000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/15/2016
• 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