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 2017-01-24 for CLEAR CARE PLUS manufactured by Alcon Laboratories, Inc..

Event Text Entries

[65941033] Greetings - thank you for your help with what is clearly a defective medical product. I discovered a serious problem with alcon laboratories, inc. Clear care plus hydrogen peroxide-based soft contact lens cleaning and disinfecting solution - https:/www. Clearcaresolution. Com/productsclear-care-plus-shtml. I've used the regular clear care contact lens cleaning solution for more than a decade without incident - http://www. Clearcaresolution. Com/products/clear-care-solution. Shtml. However, when purchasing and trying their newly released clear care plus version with an ingredient they term hydraglyde apparently a wetting solution in the product, which alcon markets as a premium product. It resulted in clouded contact lenses. It was like looking through a fog with helps and such, especially looking forward bright light. I thought the problem was with my eyes. I also experienced burning, which could only mean that the hydrogen peroxide was not fully neutralized in the disinfecting container they provide. Most disturbing, upon removing the lenses from my eyes, the cloudiness persisted without the lenses for several hours. I almost made an appointment with my ophthalmologist but suspected it may be the clear care plus product since this was the only change in my contact lens cleaning and disinfecting regimen i'd made. I discarded several pairs of new lenses in the process before i reached this hypothesis and purchased the regular version i've used for years and viola - lenses were crystal clear after cleaning, just as they'd always been. I then did a (b)(6) search and discovered i was right: there are countless reports and reviews online that describe exactly my experience with the product. This, for example, are some reviews or amazon. Com: http://amzn. To/2kojtwu. Please note that the brand and type of my soft contact lenses has remained the same since 2005 - bausch + lomb softens multifocals. The only variable this experience is the switch to clear care plus from regular clear care. Before writing to you to report this, i did call their customer service number today at (b)(6) and reached the product problem reporting department which was a voice mail system. I left a detailed verbal report of the problem i experienced which i cannot imagine they're unaware of by now, but the product has not been recalled and no warning notifications to my knowledge have been released. I did mention that i would be notifying the fda and i'm awaiting a callback from them. Thanks very much for investigating this obviously defective product, one which appears causes serious and/or lasting damage. (b)(6).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5067481
MDR Report Key6279342
Date Received2017-01-24
Date of Report2017-01-24
Date of Event2017-01-23
Date Added to Maude2017-01-26
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 Use3
Previous Use Code3
Event Type3
Type of Report0

Device Sequence Number: 0

Brand NameCLEAR CARE PLUS
Generic NameSOFT LENS
Product CodeLPN
Date Received2017-01-24
Lot NumberH14123-1215
Device Expiration Date2018-08-31
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No0
Device Event Key0
ManufacturerALCON LABORATORIES, INC.

Device Sequence Number: 1

Brand NameCLEAR CARE PLUS
Generic NameSOFT LENS
Product CodeMRC
Date Received2017-01-24
Lot NumberH14123-1215
Device Expiration Date2018-08-31
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerALCON LABORATORIES, INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-01-24

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