MAUDE Adverse Event Report: COOPERVISION LENS CARE LTD. ALL IN ONE LIGHT (MULTI-PURPOSE SOLUTION)

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

Patient Problems Corneal Ulcer (1796); Keratitis (1944); Loss of Vision (2139); Corneal Infiltrates (2231); Fungal Infection (2419)

Event Type  Injury  

Manufacturer Narrative

Analysis cannot be performed as no product was returned for evaluation.The association between the coopervision device and the event is unconfirmed.

Event Description

The patient alleges she experienced a corneal ulcer in the right (od) eye while using the product and experienced a loss of vision.The patient indicates that she has undergone more than two months of treatment and still has not recovered vision in the right eye.This event is being reported in an abundance of caution due to incomplete diagnosis, lack of medical information, and unknown resolution.

Event Description

New medical information received 06 august 2018.Heath care professional indicates the patient experienced moderate epithelial and stromal edema and corneal infiltrates, central corneal opacity, and decreased vision.The location, size and severity of the opacity is not specified.The patient was diagnosed with fungal (mycotic) keratitis and prescribed amphotericin b, voriconazole, and ciprofloxacin.The resolution remains unknown.If additional medical information is received, a follow-up report will be submitted.

• Brand Name: ALL IN ONE LIGHT (MULTI-PURPOSE SOLUTION)
• Type of Device: ALL IN ONE LIGHT (MULTI-PURPOSE SOLUTION)
• Manufacturer (Section D): COOPERVISION LENS CARE LTD.; mace industrial estate; ashford; kent, TN24 8EP; UK TN24 8EP
• MDR Report Key: 7658076
• MDR Text Key: 113006760
• Report Number: 9615939-2018-00002
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• PMA/PMN Number: K130734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability