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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ACUVUE OASYS WITH HYDRALUXE 8.5 LENSES, SOFT CONTACT, DAILY WEAR

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JOHNSON & JOHNSON VISION CARE, INC. ACUVUE OASYS WITH HYDRALUXE 8.5 LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Lot Number J002LSM 0M1
Device Problem Material Deformation (2976)
Patient Problem Insufficient Information (4580)
Event Date 01/10/2022
Event Type  malfunction  
Event Description
This has now happened about a dozen times with this batch. Wrinkled edges that are extremely uncomfortable that i needed to use new ones. Fda safety report id # (b)(4).
 
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Brand NameACUVUE OASYS WITH HYDRALUXE 8.5
Type of DeviceLENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
JOHNSON & JOHNSON VISION CARE, INC.
MDR Report Key13251249
MDR Text Key283948402
Report NumberMW5106620
Device Sequence Number1
Product Code LPL
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 01/10/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/12/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot NumberJ002LSM 0M1
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided

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