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

Model Number PT3MP355WD1

Device Problem Insufficient Information (3190)

Patient Problems Eye Burn (2523); Caustic/Chemical Burns (2549)

Event Date 07/30/2015

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.The complaint is unconfirmed.The association between coopervision lenses and the incident is unconfirmed.

Event Description

The manufacturer was informed by a third party representing a cvi business partner that a consumer had allegedly experienced a chemical burn to their cornea after use of a cvi solution.The consumer went to a hospital and received medical treatment for the chemical burns.Good faith efforts were made to obtain additional information without results.In an abundance of caution this event is being reported based on the alleged diagnosis (chemical burns to the cornea) and permanent injury is unknown.

• Brand Name: ONE STEP PEROXIDE (PLATINUM)
• Type of Device: MULTI LENS CARE SYSTEM
• Manufacturer (Section D): SAUFLON PHARMACEUTICALS, LTD; mace industrial estate; ashford, kent kent TN24 8EP; UK TN24 8EP
• Manufacturer (Section G): SAUFLON PHARMACEUTICALS; mace industrial estate; ashford, kent kent TN24 8EP; UK TN24 8EP
• Manufacturer Contact: alex jordan ; 5870 stoneridge drive; suite 1; pleasanton, CA 94588 ; 9256213782
• MDR Report Key: 5043395
• MDR Text Key: 24653053
• Report Number: 9615939-2015-01006
• 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: other
• Reporter Occupation: Other
• Report Date: 08/27/2015

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 Model Number: PT3MP355WD1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/31/2015
• 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): Other