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

Lot Number ASKU

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 06/26/2017

Event Type  Injury  

Manufacturer Narrative

The lot number was not provided and the complaint sample was not made available for evaluation.The manufacturing review did not indicate that this complaint was due to the manufacturing process.No complaint or manufacturing trend was identified.The root cause could not be determined.(b)(4).

Event Description

As initially reported on 07/13/2017 by the consumer via email, the consumer experienced moderate eye pain and severe light sensitivity on (b)(6) 2017.The consumer noted other presented symptoms such as foreign body sensation, dry eyes and gritty feeling which reportedly developed gradually for two days.It was reported that the consumer went to the eye clinic and was diagnosed with 'corneal ulcer' with unspecified eye location and unspecified treatment.At the time of report, the corneal ulcer resolved and consumer switched to contact lens as the consumer can no longer use a clear care solution.Additional information was requested but not yet received.

• Brand Name: CLEAR CARE
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): ALCON LABORATORIES, INC.; 6201 south freeway; fort worth TX 76134
• Manufacturer (Section G): ALCON LABORATORIES, INC.; 6201 south freeway; fort worth TX 76134
• Manufacturer Contact: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 6777598
• MDR Text Key: 82170822
• Report Number: 1610287-2017-00057
• 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
• Type of Report: Initial
• Report Date: 08/09/2017

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: 07/13/2017
• Initial Date FDA Received: 08/09/2017
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other