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

Device Problem Use of Device Problem (1670)

Patient Problems Inflammation (1932); Intraocular Infection (1933); Acanthameba Keratitis (1945); Visual Impairment (2138); Ulcer (2274)

Event Date 02/01/2017

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

Received adverse incident report from (b)(6).Patient reports that the device caused an eye infection, eye ulcer and acanthamoeba keratitis.The patient experienced eye inflammation and impaired vision and sought medical care.Patient was prescribed medication and was told it could be months before the eye health returned to normal.Per the eye care provider, the patient was wearing the lenses overnight when the incident occurred and was aware of the risks of overnight wear.Good faith efforts have been made to obtain medical information without success.This event is being reported out of an abundance of caution due to incomplete diagnosis, lack of medical information, and unknown resolution.

• 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; UK S031 4RF
• Manufacturer (Section G): COOPERVISION MANUFACTURING, LTD.; south point; hamble unit 2; southampton, hampshire S031 4RF; UK S031 4RF
• Manufacturer Contact: melissa torpey ; 5870 stoneridge drive; suite 1; pleasanton, CA 94588 ; 5857569874
• MDR Report Key: 6394706
• MDR Text Key: 69617440
• Report Number: 9614392-2017-00012
• 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: foreign
• Type of Report: Initial
• Report Date: 03/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2017
• 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
• Date Manufacturer Received: 02/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 50 YR