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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. ACUVUE OASYS BRAND CONTACT LENS LENSES SOFT CONTACT, DAILY WEAR

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JOHNSON & JOHNSON SURGICAL VISION, INC. ACUVUE OASYS BRAND CONTACT LENS LENSES SOFT CONTACT, DAILY WEAR Back to Search Results
Lot Number L003G4633WK
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/07/2019
Event Type  malfunction  
Event Description
Received expired contact lenses for my daughter from (b)(6). Manufacturer: johnson and johnson vision care, (b)(4), usa seller. (b)(6); product: acuvue oasys brand contact lens, order number: 174215, lot and expiry date:lot # l003g4633wk, 2018-01-05; lot # l003n6t3k4, 2018-7-11; lot # l0033n6t3kg, 2018-7-11; lot # l003n6t3jb, 2018-07-11; lot # l003g463wl, 2018-01-05; lot # l003g463wl, 2018-01-05. The lens were received today.
 
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Brand NameACUVUE OASYS BRAND CONTACT LENS
Type of DeviceLENSES SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
JOHNSON & JOHNSON SURGICAL VISION, INC.
MDR Report Key8231576
MDR Text Key132911707
Report NumberMW5082987
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 Family Member or Friend
Type of Report Initial
Report Date 01/07/2019
6 Devices were Involved in the Event: 1   2   3   4   5   6  
0 Patients were Involved in the Event:
Date FDA Received01/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date01/05/2018
Device Lot NumberL003G4633WK
Was Device Available for Evaluation? Yes
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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