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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN WALDO CONTACT LENSES; LENSES, SOFT CONTACT, DAILY WEAR
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UNKNOWN WALDO CONTACT LENSES; LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Headache (1880); Blurred Vision (2137)
Event Date 01/07/2019
Event Type  Injury  
Event Description
Over the last few months, my vision has been getting pretty bad.I wear contact lenses, and i do try to take them out daily, unless i fall asleep in them.Things that i have been able to see are just blurry, i can see well far away, bridges, landmarks, etc, but when it comes to faces or signs with wording on them, that are in the distance, they are just so much harder to read and make out and i know i was able to see and read these things in the past.I switched to a brand called waldo last year sometime, the contacts feel good in my eyes, but i¿m not sure what¿s making me have the blurry vision and headaches and more migraines than usual too.I also thought about my phone, i have a (b)(6) and i use the retina scanner to unlock my phone.I was thinking maybe that was causing my vision to worsen.I¿ve (b)(6) both things, haven¿t seen a lot of concern for either situations, bad contacts or the phone¿s eye scanner.I just thought maybe i would reach out to you guys and see if any other people have been having these kinds of issues lately.
 
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Brand Name
WALDO CONTACT LENSES
Type of Device
LENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
UNKNOWN
MDR Report Key8403524
MDR Text Key138506205
Report NumberMW5084758
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 03/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Disability;
Patient Age36 YR
Patient Weight73
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