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

Lot Number ASKU

Device Problem Insufficient Information (3190)

Patient Problems Corneal Clouding/Hazing (1878); Complaint, Ill-Defined (2331)

Event Type  Injury  

Manufacturer Narrative

The complaint product has not been returned for evaluation.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.(b)(4).

Event Description

It was reported by an eye care professional (ecp) that a patient came in and had a problem with their cornea after using the solution.It was noted that the cornea did not stain at all, but ¿caused a stromal haze in the center¿.The patient saw rainbows and hazy vision and it took a week for the patient¿s vision to clear up.Additional information has been requested but not yet received.

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.The manufacturer internal reference number is: (b)(4).

• 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: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 5886662
• MDR Text Key: 52487999
• Report Number: 1610287-2016-00088
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/27/2016

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: Lay User/Patient
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/26/2016
• Initial Date FDA Received: 08/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/27/2016
• 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