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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOLOTICA INDUSTRIA E COMERCIO LTDA SOLOTICA HIDROCOR LENSES; LENSES, SOFT CONTACT, DAILY WEAR
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SOLOTICA INDUSTRIA E COMERCIO LTDA SOLOTICA HIDROCOR LENSES; LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Dry Eye(s) (1814); Itching Sensation (1943); Burning Sensation (2146)
Event Date 07/05/2021
Event Type  Injury  
Event Description
I soaked solotica contact lenses in water for 24 hours then i wash my hands and clean them with the same solution "renu solution" i could not wear them and i remove them quickly.It is like something burning in my eyes and caused itchiness.Next day, i woke with eyes full of eye sores, dryness and itchiness.I bought 3 pairs for my relatives and i as we used to wear solotica yearly contact lenses and the last time was in 2017 as it is fda approved.Nowadays, i believe that the quality has been totally changed.I also checked people's reviews on (b)(6) and on many websites to find out that i am not the only one who had the issue.I reported to (b)(6) where i bought them but they denied everything.I use hylo-gel eye drops as well for relief.Fda safety report id # (b)(4).
 
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Brand Name
SOLOTICA HIDROCOR LENSES
Type of Device
LENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
SOLOTICA INDUSTRIA E COMERCIO LTDA
MDR Report Key12137417
MDR Text Key260795985
Report NumberMW5102380
Device Sequence Number1
Product Code LPL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 07/06/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/07/2021
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age25 YR
Patient Weight160
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