CLEAR CARE PLUS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-25 for CLEAR CARE PLUS manufactured by Alcon Research, Llc.

Event Text Entries

[181391225] Eye was burned. When staying with a family member i borrowed their contact solution. It was night and i noticed the bottle had a red top but i just assumed it was generic brand. I put the solution in my case and took out my contact. The following morning i put the contact in my eye and experienced severe pain. The pain was so severe i couldn? T open my eye to take out the contact. I realized that i had used clear care solution plus solutions instead of regular saline and had burned my eye. The eye was extremely red with constant watering. I used refreshed pm ointment to ease the pain but at day 3 it is still very red although the pain has improved. I am a pharmacist by training and the notations on this bottle are clearly not a sufficient warning. The red top and band just seems like bottle branding perhaps for generic. I would strongly encourage the fda to reconsider and have any manufactures of such cleaning solutions to require and entirely different shaped bottle, a large warning on both sides of the bottle and most importantly a child restraint top which would make the user realize it is not saline. I have read many reports of his happening online and also spoke to multiple friends who experienced the same thing but never reported to the fda. I am certain that the incidence of the occurring is much greater than reported. Additionally, not only does this result in significant pain, burning and inflammation but it can also cause more significant damage. Thought it was saline solution.
Patient Sequence No: 1, Text Type: D, B5


[181391227] Eye was burned. When staying with a family member i borrowed their contact solution. It was night and i noticed the bottle had a red top but i just assumed it was generic brand. I put the solution in my case and took out my contact. The following morning i put the contact in my eye and experienced severe pain. The pain was so severe i couldn? T open my eye to take out the contact. I realized that i had used clear care solution plus solutions instead of regular saline and had burned my eye. The eye was extremely red with constant watering. I used refreshed pm ointment to ease the pain but at day 3 it is still very red although the pain has improved. I am a pharmacist by training and the notations on this bottle are clearly not a sufficient warning. The red top and band just seems like bottle branding perhaps for generic. I would strongly encourage the fda to reconsider and have any manufactures of such cleaning solutions to require and entirely different shaped bottle, a large warning on both sides of the bottle and most importantly a child restraint top which would make the user realize it is not saline. I have read many reports of his happening online and also spoke to multiple friends who experienced the same thing but never reported to the fda. I am certain that the incidence of the occurring is much greeter than reported. Additionally, not only does this result in significant pain, burning and inflammation but it can also cause more significant damage. Thought it was saline solution.
Patient Sequence No: 2, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5093273
MDR Report Key9753409
Date Received2020-02-25
Date of Report2020-02-24
Date of Event2020-02-22
Date Added to Maude2020-02-26
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameCLEAR CARE PLUS
Generic NameACCESSORIES, SOFT LENS PRODUCTS
Product CodeLPN
Date Received2020-02-25
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerALCON RESEARCH, LLC

Device Sequence Number: 101

Product Code---
Date Received2020-02-25
Device Sequence No101
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-25
201. Other 2020-02-25

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