MAUDE Adverse Event Report: ALCON RESEARCH, LTD. CLEAR CARE SOLUTION; ACCESSORIES, SOFT LENS PRODUCTS

Device Problem Defective Device (2588)

Patient Problems Loss of Vision (2139); Burning Sensation (2146)

Event Date 01/01/2018

Event Type  No Answer Provided  

Event Description

Poured clear care plus on my contact lens and placed in eye, not knowing it was an eye lens cleaner that would burn your eye.Medication administered to or used by patient: no; outcome: final outcome, temporary harm/injury; final outcome comment: had to go to (treatment facility); visit to clinic/doctor ; visit to an emergency room, more medicine to reduce or relieve the possible bad effects of error.When and how was error discovered: burning eye and loss of vision for about 48 hours.Reporter¿s recommendations: product should be taken off the market and be given out from doctor or pharmacy with strict instructions.(b)(6), access number: (b)(4).

• Brand Name: CLEAR CARE SOLUTION
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): ALCON RESEARCH, LTD.
• MDR Report Key: 8227578
• MDR Text Key: 132567861
• Report Number: MW5082907
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1