MAUDE Adverse Event Report: SAUFLON PHARMACEUTICALS, LTD ONE STEP PEROXIDE (PLATINUM)

Lot Number 133270

Device Problem Insufficient Information (3190)

Patient Problems Conjunctivitis (1784); Burning Sensation (2146)

Event Type  Injury  

Manufacturer Narrative

Analysis cannot be performed.No lenses were returned for evaluation.The association between coopervision lenses and the event is unconfirmed.

Event Description

It was initially reported that the patient had experienced severe stinging/ burning of the eyes and could not see.Cvi established communication with the patient and was informed that the patient was taken by ambulance to the hospital, where they were diagnosed with chemical conjunctivitis.Subsequently, the patient has been "in and out" of the hospital.The patient advised that they will not follow up with their treating facility to have the necessary documents completed to obtain medical information.Cvi made a reasonable and good faith effort to obtain medical information without results.The event is being reported out of an abundance of caution per the alleged chemical conjunctivitis diagnosis in the absence of medical information.

• Brand Name: ONE STEP PEROXIDE (PLATINUM)
• Type of Device: ONE STEP PEROXIDE (PLATINUM)
• Manufacturer (Section D): SAUFLON PHARMACEUTICALS, LTD; mace industrial estate; ashford, kent TN24 8EP; UK TN24 8EP
• Manufacturer (Section G): SAUFLON PHARMACEUTICALS, LTD; mace industrial estate; ashford, kent TN24 8EP; UK TN24 8EP
• Manufacturer Contact: alex jordan ; 5870 stoneridge drive; suite 1; pleasanton, CA 94588 ; 9256213782
• MDR Report Key: 5261680
• MDR Text Key: 32561172
• Report Number: 9615939-2015-01008
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K010559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 133270
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/05/2015
• Initial Date FDA Received: 12/02/2015
• 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