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U.S. Department of Health and Human Services

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

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JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND 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 Irritation (1941); Pain (1994); Discomfort (2330)
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
On (b)(6) 2017 an email was received from a patient (pt) who reported while wearing the 1-day acuvue moist brand contact lenses one eye (affected eye was not provided) became ¿extremely irritated¿. The pt reported wearing the lens brand for many years without issue. The pt reported ¿i had to stop wearing contacts figuring it would resolve¿. The pt went to an eye care provider (ecp) and was advised there was ¿scar tissue¿ but no known cause. Pt reported the event resolved and was able to resume contact lens wear after switching to a different ¿batch¿ of the same brand and all was well. Pt reported he/she resumed using the same brand and reports now both eyes hurt and pt gets relief when the lenses are removed. Pt stated he/she can ¿physically feel a gritty texture on the lenses from this lot! it is like they are coated in plastic. ¿ pt reported while wearing the lenses he/she experiences pain and discomfort. Pt reported eyes are still hurting and will have to return to the ecp. No additional information was received. Multiple attempts were made to contact the pt for additional information, but nothing additional has been received. The date of the event was not provided. 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 2741990106 was produced under normal conditions. 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 Name1-DAY ACUVUE MOIST
Type of DeviceLENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND
one technological park plassey
limerick
EI
Manufacturer Contact
rose harrell
7500 centurion parkway
jacksonville, FL 32256
9044433364
MDR Report Key7143716
MDR Text Key95926160
Report Number9617710-2017-05079
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N18033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 11/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/01/2022
Device Catalogue Number1DM
Device Lot Number2741990106
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/30/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/09/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 12/22/2017 Patient Sequence Number: 1
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