MAUDE Adverse Event Report: COOPERVISION MANUFACTURING LTD UNKNOWN

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

Patient Problems Unspecified Infection (1930); Nausea (1970); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Analysis cannot be performed, and root cause cannot be identified.No lenses were returned for evaluation and no lot number reported.The association between the coopervision device and the event is unconfirmed.

Event Description

The patient alleges that she experienced an infection type reaction in the eye(s) after using the device with symptoms of pain and nausea.The patient states that she self-medicated with eye drops, unspecified medication, from a previous incident related to cataract surgery.Once the incident resolved the patient resumed lens use and experienced a similar incident.The contact lens brand name/device name and manufacturer is unknown, it is unconfirmed if this is a coopervision device.Good faith efforts have been made to obtain additional information without success, additional information is unknown.This event is being reported in an abundance of caution due to incomplete diagnosis, lack of medical information, and unknown resolution.

• Brand Name: UNKNOWN
• Type of Device: UNKNOWN
• Manufacturer (Section D): COOPERVISION MANUFACTURING LTD; south point, hamble unit 2; southampton; hampshire, SO31 4RF; UK SO31 4RF
• Manufacturer (Section G): COOPERVISION MANUFACTURING LTD; south point, hamble unit 2; southampton; hampshire, SO31 4RF; UK SO31 4RF
• Manufacturer Contact: melissa torpey ; 5870 stoneridge drive; suite 1; pleasanton, CA 94588 ; 5857569874
• MDR Report Key: 8346570
• MDR Text Key: 136467511
• Report Number: 9614392-2019-00005
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 02/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2019
• 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: 01/19/2019
• 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