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U.S. Department of Health and Human Services

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

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JOHNSON & JOHNSON VISION CARE, INC. ¿ US 1-DAY ACUVUE MOIST LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Catalog Number 1DM
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Corneal Ulcer (1796); Red Eye(s) (2038); Discomfort (2330)
Event Type  Injury  
Manufacturer Narrative
(b)(6).
 
Event Description
On (b)(6) 2019 a patient (pt) from (b)(6) sent an email to report a diagnosis of corneal ulcer (affected eye not provided) while wearing the 1-day acuvue moist brand contact lenses. The pt reported the suspect lens pinched the eye which caused the ulcer. On (b)(6) 2019 additional medical information was received from the pt: pt reported an od scratching discomfort and redness after approximately 2 hours after insertion of a new lens. The pt reported that a piece was missing from the edge of the lens. The pt went to the eye care provider (ecp) who advised the od was scratched due to the lens defect. The pt was prescribed an eye drop (name of eye drop and frequency prescribed were not provided) every 8 hours for 1 week. The pt reported the eye drops were used for 1 day and the pt returned to contact lens wear. The pt reported the od is currently fine. The pt reported while at the ecp, a routine eye exam was also performed. On (b)(6) 2019 an email was received from the pt with the ecp contact information and medication prescribed: poen carboxymethylcellulose 1% (lubricating eye drop), every 8hs. On (b)(4) 2019 a call was placed to the pt¿s ecp and additional information was provided. A representative at the ecp¿s office reported the pt had not been seen in the office or treated for a corneal ulcer or ¿any eye issues¿. The representative reported the pt was seen for a contact lens exam and no medication was prescribed. The event date was reported as (b)(6) 2019. No additional medical information has been received. This od corneal ulcer event is being reported as a worst-case event as the diagnosis and treatment were unable to be verified. The suspect od lens was requested but has not yet been received. A lot history review was performed and revealed the following: the batch record did not show any abnormalities in monomer and solution testing. All parameters tested were within specification. All sterilization requirements were successfully completed. Lot 1373840108 was produced under normal conditions. If any further relevant information is received, a supplemental report will be filed.
 
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Brand Name1-DAY ACUVUE MOIST
Type of DeviceLENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
JOHNSON & JOHNSON VISION CARE, INC. ¿ US
7500 centurion parkway
jacksonville FL
Manufacturer Contact
rose harrell
7500 centurion parkway
jacksonville, FL 32256
9044433364
MDR Report Key8333688
MDR Text Key136021898
Report Number1057985-2019-00020
Device Sequence Number1
Product Code LPL
Combination Product (y/n)Y
Reporter Country CodeAR
PMA/PMN Number
N18033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,health profe
Reporter Occupation
Type of Report Initial
Report Date 01/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number1DM
Device Lot Number1373840108
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/17/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/18/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 02/12/2019 Patient Sequence Number: 1
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