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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 TRUEYE (NARA A) LENSES, SOFT CONTACT, DAILY WEAR

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JOHNSON & JOHNSON VISION CARE, INC. ¿ US 1-DAY ACUVUE TRUEYE (NARA A) LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Catalog Number 1D4
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Conjunctivitis (1784); Dry Eye(s) (1814); Iritis (1940); Keratitis (1944); Neovascularization (1978)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Initial reporter phone number: (b)(6).
 
Event Description
On 07nov2019 an email was from a patient (pt) who reports being treated by an eye care provider (ecp) for staining (affected eye not provided) while wearing the 1-day acuvue® trueye® brand contact lens. On 11nov2019 additional medical information was provided by the pt: the pt went to the ecp and diagnosed with staining on os. The pt was advised to discontinue contact lens wear for 7 days and prescribed gatifloxacin ophthalmic solution 0. 3%, hyalein ophthalmic solution 0. 1% and tarivid eye ointment 0. 3%. The pt visited the ecp 3 times in (b)(6) 2019. On 19nov2019 additional medical information was received from the pts treating ecp: diagnosis: corneal erosion, acute conjunctivitis and keratitis superficialis diffuse os; slight iritis os was also noted os. Focal site: ¿severe staining os was in the superior part of the cornea, which might be on pupil. Staining was also noted in the inferior part. Fine keratitis diffused in periphery¿; infectiveness: unconfirmed; va: not affected; va was not measured; ecp visit dates: (b)(6) 2019; treatment: gatifloxacin ophthalmic solution 0. 3% tid, hyalein ophthalmic solution tid, tarivid eye ointment hs were prescribed on (b)(6) 2019, event recovered and all medications were discontinued on (b)(6) 2019. The ecp recommended the pt to apply softear opthalmic solution for dry eye. The pt was not instructed to discontinue cl wear or to return to the clinic for follow-up. The last date was ecp visit was (b)(6) 2019. The ecp instructed pt to wear lenses ¿within 12 hours and rest the eye once a week. ¿ ¿contact lens over-wear might be the cause of neovascularization os. ¿ no additional medical information was received. The date of event is reported as (b)(6) 2019. The lot number of the suspect is unknown. The suspect os contact lens was discarded. No evaluation can be completed. If any further relevant information is received, a supplemental report will be filed.
 
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Brand Name1-DAY ACUVUE TRUEYE (NARA A)
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 Key9446151
MDR Text Key185043407
Report Number1057985-2019-00141
Device Sequence Number1
Product Code LPL
Combination Product (y/n)Y
Reporter Country CodeJA
PMA/PMN Number
K073485
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 11/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number1D4
Device Lot NumberUNK-1D4
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/19/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 12/10/2019 Patient Sequence Number: 1
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