MAUDE Adverse Event Report: COOPERVISION MANUFACTURING, LTD BIOFINITY SPHERE (COMFILCON A); LENSES, SOFT CONTACT, EXTENDED WEAR

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

Customer service received information on (b)(6)-2014 from an eye care practice that a (b)(6) female patient wearing biofinity lenses had been seen at an eye hospital and is recovering from an eye infection.The patient sometimes sleeps in the lenses.Date of onset is unknown.Resolution of condition is unknown.Coopervision is reporting this event in an abundance of caution based on the alleged infection.Good faith effort was made to obtain additional information but response was received.

Manufacturer Narrative

The contact lens was not returned for inspection.The complaint is unconfirmed.The association between coopervision lenses and the incident is uncomfirmed.

• Brand Name: BIOFINITY SPHERE (COMFILCON A)
• Type of Device: LENSES, SOFT CONTACT, EXTENDED WEAR
• Manufacturer (Section D): COOPERVISION MANUFACTURING, LTD; southpoint, hamble; unit 2; southampton, S031 4RF; UK S031 4RF
• Manufacturer (Section G): COOPERVISION, MANUFACTURING LTD; southpoint, hamble unit 2; southampton, SO31 4RF; UK SO31 4RF
• Manufacturer Contact: joe nesci ; 6150 stoneridge mall road; suite 370; pleasanton, CA 94588-3176 ; 9256213775
• MDR Report Key: 4048694
• MDR Text Key: 4901757
• Report Number: 9614392-2014-00023
• 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: Physician
• Type of Report: Initial
• Report Date: 09/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 14 YR