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

Lot Number 127592

Device Problem Insufficient Information (3190)

Patient Problems Swelling (2091); Blurred Vision (2137)

Event Date 07/29/2016

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.

Event Description

The patient experienced swelling and blurred vision after use of one step peroxide lens care system, which resulted in a permanent reduction of visual acuity.Medical attention was sought.No additional information has been obtained.This event is being reported out of abundance of caution because it is unknown if the blurry vision resolved.

• Brand Name: ONE STEP PEROXIDE (PLATINUM) MULTI LENS CARE SYSTEM
• Type of Device: ONE STEP PEROXIDE (PLATINUM) MULTI LENS CARE SYSTEM
• 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; unit 8; ashford, kent TN24 8EP; UK TN24 8EP
• Manufacturer Contact: ashley nguyen ; 5870 stoneridge drive; suite 1; pleasanton, CA 94588 ; 9256604414
• MDR Report Key: 5998571
• MDR Text Key: 56443896
• Report Number: 9615939-2016-01000
• 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
• Type of Report: Initial
• Report Date: 09/19/2016

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: No Information
• Device Lot Number: 127592
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/19/2016
• Initial Date FDA Received: 10/04/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other