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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. 1-DAY ACUVUE MOIST -5.25 BC 8.5 LENSES, SOFT CONTACT, DAILY WEAR

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JOHNSON & JOHNSON VISION CARE, INC. 1-DAY ACUVUE MOIST -5.25 BC 8.5 LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Lot Number 216678 0697
Device Problems Material Puncture/Hole (1504); Component Missing (2306)
Patient Problem Insufficient Information (4580)
Event Date 09/14/2021
Event Type  malfunction  
Event Description
Improperly formed contact lens. Several lenses in this batch had missing material, one had a complete hole, one had a half-moon hole out of the edge of the lens. Others had smaller flaws, often not noticeable until placed on the eye. Fda safety report id # (b)(4).
 
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Brand Name1-DAY ACUVUE MOIST -5.25 BC 8.5
Type of DeviceLENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
JOHNSON & JOHNSON VISION CARE, INC.
MDR Report Key12481116
MDR Text Key272127292
Report NumberMW5103989
Device Sequence Number1
Product Code LPL
Reporter Country CodeUS
PMA/PMN Number
N18033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 09/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number216678 0697
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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