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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON AND JOHNSON VISION CARE, INC - US 1-DAY ACUVUE® MOIST®; LENSES, SOFT CONTACT, DAILY WEAR
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JOHNSON AND JOHNSON VISION CARE, INC - US 1-DAY ACUVUE® MOIST®; LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Catalog Number UNK-SOFT CONTACT LENSES
Device Problem No Apparent Adverse Event (3189)
Patient Problems Corneal Ulcer (1796); Red Eye(s) (2038)
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
On (b)(6) 2017 our affiliate in (b)(6) contacted an eye care provider (ecp) for a medical interview for separate medical issue with the patient (pt).During the phone call the ecp representative reported an additional medical issue in the patient¿s (pt) medical file.The pt had a consultation in (b)(6) 2016 and the pt was advised to discontinue contact lens wear due to a diagnosis of corneal ulcer and redness (affected eye was not provided).The pt returned to the ecp on (b)(6) 2016 with no return visit to the clinic was noted.It was not known what acuvue contact lens brand the pt was wearing at the time of the diagnosis.No additional information was provided.The lot number was not provided and it is unknown if the suspect product is available.Multiple follow-up phone calls were placed to the pt for additional information, but no additional information has been received.This event is being reported as a worst-case event.If additional information is received it will be reported within 30 days of receipt.Serious reportable event trends are reviewed quarterly in franchise management review meetings.
 
Manufacturer Narrative
On 11jan2018 the lot number was updated from unk product to 1-day acuvue moist brand contact lenses.On 12jan2018 a call was placed to the pt.The pt reported he/she presented to the clinic wearing the 1-day acuvue moist brand contact lenses.The pt agreed to sign a consent form for release of additional medical information.On 15jan2018 the pt reported that the suspect product and the lot number are not available as it was discarded.No additional information has been received.Additional information has been requested.If additional information is received it will be reported within 30 days of receipt.Serious reportable event trends are reviewed quarterly in franchise management review meetings.
 
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Brand Name
1-DAY ACUVUE® MOIST®
Type of Device
LENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
JOHNSON AND JOHNSON VISION CARE, INC - US
7500 centurion parkway
jacksonville FL
MDR Report Key7169472
MDR Text Key96587185
Report Number1057985-2018-00003
Device Sequence Number1
Product Code LPN
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 01/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Catalogue NumberUNK-SOFT CONTACT LENSES
Was Device Available for Evaluation? No
Date Manufacturer Received01/11/2018
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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