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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 No Apparent Adverse Event (3189)
Patient Problems Corneal Ulcer (1796); Pain (1994); Red Eye(s) (2038); Swelling (2091)
Event Date 12/08/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
On (b)(6) 2017 our affiliate in (b)(4) received a report from the pharmaceuticals and medical devices agency (pmda) via fax.An eye care provider (ecp) reported on (b)(6) 2017 that a patient (pt) was diagnosed with a corneal ulcer in the left eye while wearing the 1-day acuvue moist brand contact lenses.The date of the event was reported as (b)(6) 2017.Pt reported to the clinic complaining of redness, pain and swelling.Pt was instructed to discontinue contact lens wear.A corneal curettage was performed and the pt wore a patch over left eye.Pt was prescribed cravit ophthalmic solution 0.5 % six times daily to the left eye.The pt was instructed to return to the clinic on (b)(6) 2017.The ecp reported that the pt ¿repeatedly bought contact lenses on internet for more than a year without seeking medical attention for contact lens prescription¿.On (b)(6) 2017 an email was received from a johnson and johnson sales representative who reported an interview with the reporting ecp is impossible.No additional information was provided and no additional medical information is expected.The lot number was not provided and it is unknown if the suspect lens is available for return.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 & JOHNSON VISION CARE, INC. ¿ US
7500 centurion parkway
jacksonville FL
Manufacturer Contact
rose harrell
7500 centurion parkway
jacksonville, FL 32256
9044433364
MDR Report Key7158355
MDR Text Key96183570
Report Number1057985-2018-00002
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
N18033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Health Professional
Type of Report Initial
Report Date 12/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Catalogue Number1DM
Device Lot NumberUNK-1DM
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/11/2017
Initial Date FDA Received01/02/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age29
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