MAUDE Adverse Event Report: SAUFLON PHARMACEUTICALS, LTD. ONE STEP PEROXIDE (PLATINUM); MULTI LENS CARE SYSTEM

Lot Number 125980

Device Problem Insufficient Information (3190)

Patient Problems Eye Injury (1845); Pain (1994)

Event Type  Injury  

Event Description

Date of event is unknown.Retailer received complaint on (b)(4) 2015 from the customer that alleges"grit" in the eye and that the eye "constantly watered." the customer went to the hospital because the pain worsened.The customer reports relates that he was advised by the doctor that his conrea was "burnt." it is unknown as to what actions were taken to either prevent or treat a permanent injury.The solution has not been returned for investigation.Follow up information has been attempted but no information has been received to date.Coopervision is reporting this event in an abundance of caution on the alleged injury.

Manufacturer Narrative

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

• Brand Name: ONE STEP PEROXIDE (PLATINUM)
• Type of Device: MULTI LENS CARE SYSTEM
• Manufacturer (Section D): SAUFLON PHARMACEUTICALS, LTD.; unit 8, mace industrial estate; ashford, kent TN24 8EP; UK TN24 8EP
• Manufacturer (Section G): SAUFLON PHARMACEUTICALS, LTD.; unit 8, mace industrial estate; ashford, kent TN24 8EP; UK TN24 8EP
• Manufacturer Contact: joe nesci ; 6150 stoneridge mall road; suite 370; pleasanton, CA 94588-3176 ; 9256213775
• MDR Report Key: 4682387
• MDR Text Key: 5638042
• Report Number: 9615939-2015-01001
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K010559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/19/2015

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
• Device Expiration Date: 03/01/2017
• Device Lot Number: 125980
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/19/2015
• Initial Date FDA Received: 04/10/2015
• 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