MAUDE Adverse Event Report: SAUFLON CL KFT SLICON SELECT DAILY / SOMOFILCON A

Lot Number R0024210

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

The date the incident occurred is unknown.Eye care practice relates that the customer was in hospital and had an "operation" for an infection of left eye because her cornea has an abscess.Additional information was requested without results.The informant relates the doctor thinks the lens "was out of order." this is being reported in an abundance of caution because the extent of the injury and outcome are unknown and that treatment of "operation" may have been prevent permanent injury.The doctor's statement may relate the event to the device.

Manufacturer Narrative

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

Manufacturer Narrative

• Brand Name: SLICON SELECT DAILY / SOMOFILCON A
• Type of Device: SLICON SELECT DAILY / SOMOFILCON A
• Manufacturer (Section D): SAUFLON CL KFT; h-2360 gyal; prologia uleti park, 4ep; gyal, budapes, 7100 ; HU 7100
• Manufacturer (Section G): SAUFLON CL KFT; h-2360 gyal; prologia uleti park, 4ep; gyal, budapest, 7810 0; HU 78100
• Manufacturer Contact: joe nesci ; 6150 stoneridge mall road; suite 370; pleasanton, CA 94588-3176 ; 9256213775
• MDR Report Key: 4698678
• MDR Text Key: 5719533
• Report Number: 3009108089-2015-01000
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• PMA/PMN Number: K130342
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Type of Report: Initial,Followup
• Report Date: 02/12/2015

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: 02/01/2018
• Device Lot Number: R0024210
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/12/2015
• Initial Date FDA Received: 04/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/17/2015
• 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): Required Intervention