MAUDE Adverse Event Report: COOPERVISION MANUFACTURING, LTD. UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fungus (1872); Acanthameba Keratitis (1945)

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

Coopervision was made aware of an event by (b)(6).The patient alleges to have contracted acanthamoeba keratitis as well as an unidentified potential fungus while wearing contact lenses, which have proved unresponsive to two and a half months of aggressive inpatient treatment, resulting in the final removal of the right (od) eye.This event is unconfirmed as additional information regarding the event is not available.It is unknown if the patient was wearing coopervision lenses at the time of the event, device details have not been made available, nor has patient or health care professional contact information.The patient indicates the event report is in reference to "all contact lenses we are not warned prevent the eyes natural defense in the form of blinking and tears from constantly naturally cleaning and protecting the cornea.The lens prevents the cornea from being exposed to this ongoing purification and in fact leads to abrasions heightening the chance of infections entering and causing serious damage to the eye." the event is being reported in an abundance of caution.

• Brand Name: UNKNOWN
• Type of Device: UNKNOWN
• 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: 6432085
• MDR Text Key: 70806155
• Report Number: 9614392-2017-00015
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/24/2017

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/15/2017
• Initial Date FDA Received: 03/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Disability