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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 Uveitis (2122); Discomfort (2330)
Event Type  Injury  
Manufacturer Narrative
Eval: no testing methods performed. No results available since no evaluation performed. Unable to confirm complaint. Device not returned.
 
Event Description
On (b)(6) 2018 a patient (pt) in (b)(6) reported discomfort in the left eye while inserting a 1-day acuvue moist brand contact lens in (b)(6) 2018. The pt reported the lens was worn about half the day and it was noted to be chipped on removal. The pt presented to the eye care provider (ecp) on (b)(6) 2018 and was diagnosed with staining and ¿incipient uveitis os¿. The pt was instructed to discontinue contact lens wear. Pt was prescribed mucosta ophthalmic suspension ud, hyalein ophthalmic solution and additional eye drops the pt was unable to recall. On (b)(6) 2018 the pt had a follow-up appointment and was not prescribed any eye drops. The pt refused to provide further information. On (b)(6) 2018 the pt consulted a different ecp and was diagnosed with staining and ¿incipient uveitis os¿. Pt was instructed to discontinue contact lens wear. Pt was given a return appointment for (b)(6) 2018, no medication was prescribed. The pt did not agree to a medical interview. The pt reported the staining is persisting and will not wear lenses. Pt has a follow-up visit with the ecp on (b)(6) 2018. On 19feb2018 a call was placed to the pt for additional medical information: the pt only reported he/she will continue to return to the clinic for follow-up. The pt refused to provide any additional information. No additional medical information is expected. The lot number is unknown and the suspect lens was discarded. 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 27mar2018 during a file review it was noted that on the initial mdr the product was not labeled for single use. The product is labeled for single use.
 
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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 Key7332597
MDR Text Key102192300
Report Number1057985-2018-00029
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 consumer,foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number1DM
Device Lot NumberUNK-1DM
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/27/2018
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: 03/12/2018 Patient Sequence Number: 1
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