MAUDE Adverse Event Report: SUAFLON PHARMACUETICALS, LTD. ONE STEP PEROXIDE (PLATINUM) / MULTI LENS CARE SYSTEM

Lot Number 142474

Device Problem Insufficient Information (3190)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Type  Injury  

Manufacturer Narrative

The bmr for batch 142474 was reviewed with no issues recorded and all product testing were within specification.The association between coopervision solution and the event is unconfirmed.

Event Description

The patient allegedly suffered from 3rd degree burns to the left (os) cornea.Treatment is unknown, however the cornea is recovering and visual acuity is down to 6/10.It is unknown if this event has fully resolved.In the absence of medical information, this event is being reported in abundance of caution based on the severity of the allegation of a 3rd degree burn to the cornea.

• Brand Name: ONE STEP PEROXIDE (PLATINUM) / MULTI LENS CARE SYSTEM
• Type of Device: ONE STEP PEROXIDE (PLATINUM) / MULTI LENS CARE SYSTEM
• Manufacturer (Section D): SUAFLON PHARMACUETICALS, LTD.; mace industrial estate; ashford, kent TN24 8EP; UK TN24 8EP
• Manufacturer (Section G): SUAFLON PHARMACUETICALS, LTD.; mace industrial estate; ashford, kent TN24 8EP; UK TN24 8EP
• Manufacturer Contact: ashley nguyen ; 5870 stoneridge drive; suite 1; pleasanton, CA 94588 ; 9256604144
• MDR Report Key: 6223842
• MDR Text Key: 63914822
• Report Number: 9615939-2017-00001
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K010559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/08/2016

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: 142474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/08/2016
• Initial Date FDA Received: 01/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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