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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ACUVUE OASYS CONTACTS; LENSES, SOFT CONTACT, EXTENDED WEAR

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JOHNSON & JOHNSON VISION CARE, INC. ACUVUE OASYS CONTACTS; LENSES, SOFT CONTACT, EXTENDED WEAR Back to Search Results
Patient Problem Blurred Vision (2137)
Event Date 12/15/2023
Event Type  Injury  
Event Description
I placed an order for new contacts with my optometrist.6 month supply (b)(6).They are blurry after half an hour.I looked it up and it's apparently common with this brand.I called my eye doctor who will not let me return or exchange them as now my prescription expired so i'm not allowed to return or exchange them.I ordered them on (b)(6) 2023 and called the day after i received them on (b)(6) 2023.I had no chance to return them at all.Contacts are the acuvue oasys brand.It is a brand i have used for years and started having issues last year which seems to be what everyone else experienced.I brought it up to my dr.At my last appointment who told me to change my solution which did not help the situation.
 
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Brand Name
ACUVUE OASYS CONTACTS
Type of Device
LENSES, SOFT CONTACT, EXTENDED WEAR
Manufacturer (Section D)
JOHNSON & JOHNSON VISION CARE, INC.
MDR Report Key18365451
MDR Text Key331085880
Report NumberMW5149403
Device Sequence Number1
Product Code LPM
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 12/15/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/19/2023
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age36 YR
Patient SexFemale
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