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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Red Eye(s) (2038); Swelling (2091); Burning Sensation (2146)

Event Date 01/01/2018

Event Type  No Answer Provided  

Event Description

Clear care plus was accidentally used to soak and clean my contacts.I sustained severe burning and redness after putting my contacts in.I could not read the small print, my (b)(6) daughter could not read it, and my (b)(6) grandson had to squint to read it.I made an emergency visit to my eye doctor, to make sure there was no damage, and there was not.But i needed a prescription for an antibiotic for both eyes, with a co-payment of (b)(6).My doctor told me she was very familiar with the product and it is a good product.However, she has had patients just like me come in after accidentally misusing the product.I lost 3 days of work as a result, so it was a costly accident.I really think this should be a prescription so that patients can be warned by the pharmacist to the dangers.The packaging is grossly misleading and the company is grossly negligent.While i was only out of pocket (b)(6).Medicare and my drug company paid a hefty price for their lack of responsibility to the consumer.Multiply this my thousands across the country that seek medical care and drug treatment it seems like an unnecessary drain on health care that we do not need.I will try to attach photo.Visit to clinic/doctor.Visit to an emergency room.More medicine to reduce or relieve the possible bad effects of the error.Other explanation: lost days at work due to weepy, red, swollen eyes; could not drive.(b)(6), access number: (b)(4).

• Brand Name: CLEAR CARE
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): ALCON LABORATORIES, INC.
• MDR Report Key: 8189833
• MDR Text Key: 131476817
• Report Number: MW5082409
• 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: Patient
• Type of Report: Initial
• Report Date: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• 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