MAUDE Adverse Event Report: ALCON LABORATORIES, INC. - FORT WORTH CLEAR CARE; ACCESSORIES, SOFT LENS PRODUCTS

Lot Number ASKU

Device Problem Insufficient Information (3190)

Patient Problem Eye Injury (1845)

Event Type  Injury  

Manufacturer Narrative

The device has not been received for analysis.The lot number is unknown.A trend related investigation was performed.No trend could be identified.The root cause could not be determined.(b)(4).

Event Description

It was reported that a consumer's husband purchased a travel size version of the contact solution for their vacation.The consumer disclosed that she used the product without completely reading the instructions.The consumer stated that she suffered a serious eye burn leaving her partially blind.She stated that she spent her vacation suffering severely.No other information was provided.Additional information has been requested but not yet received.

• Brand Name: CLEAR CARE
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): ALCON LABORATORIES, INC. - FORT WORTH; 6201 south freeway; fort worth TX 76134
• Manufacturer (Section G): ALCON LABORATORIES, INC. - FORT WORTH; 6201 south freeway; fort worth TX 76134
• Manufacturer Contact: janet moran ; 6201 south freeway; mail stop r3-48; fort worth, TX 76134 ; 8176152742
• MDR Report Key: 4658968
• MDR Text Key: 21217044
• Report Number: 1610287-2015-00507
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031521
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Patient
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/03/2015

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 Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/18/2015
• Initial Date FDA Received: 04/03/2015
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Disability