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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 Conjunctivitis (1784); Foreign Body Sensation in Eye (1869); Red Eye(s) (2038); Discharge (2225); Discomfort (2330)
Event Date 12/27/2017
Event Type  Injury  
Event Description
On 29jan2018 a patient sent an email reporting a diagnosis of a ¿conjunctivitis infection¿ while using the 1-day acuvue moist brand contact lenses on (b)(6) 2017. The pt reported the moist lenses are ¿not as comfortable and are more flimsy¿ than the 1-day acuvue oasys brand contact lenses. The pt reported the eye care professional (ecp) gave the pt a prescription for the 1-day oasys lenses, but when the pt purchased the lenses at an optical store, the pt was given the 1-day acuvue moist brand lenses. On 16feb2018 the pt reported additional information as follows: the pt is not sure what the ecp wrote on the contact lens prescription, but reported the ecp told the pt ¿we will keep you in the same lens¿. Pt reported the lenses feel like there is fuzz in the eye or that the lenses are torn. The pt reported symptoms of redness ou and ¿yellow pus¿ and reported the os was worse than the od. The pt was traveling and had to go to a different ecp who diagnosed the pt with conjunctivitis ou. Pt was prescribed ciprofloxacin 0. 3% 2 drops q 2 hours while awake for the first 2 days, then q 4 hours while awake for 5 days; no contact lens wear. Pt could not recall the treating ecp contact information. The pt was advised to follow-up with ecp if the symptoms did not improve. Pt reported after 24 hours the eyes started to get better and the pt used the eye drops ¿around the clock¿. Pt returned to contact lens wear until about 5 days after the ¿recommended time¿. On 20feb2018 a call was placed to the pts prescribing ecp for additional information, but the pt did not appear in the ecp¿s database. The ecp was no longer working at the office. No additional information was obtained. No additional information is expected. This submission is for the pts od event. The event for the pts os will be submitted in a separate submission. The suspect lenses were discarded. 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 5726480102 was produced under normal conditions. 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 (b)(6) 2018 during a file review it was noted that on the initial mdr it was incorrectly selected in section. That 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. ¿ IRELAND
one technological park plassey
limerick
EI
MDR Report Key7342939
MDR Text Key102580206
Report Number9617710-2018-05026
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
PMA/PMN Number
N18033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 03/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/01/2022
Device Catalogue Number1DM
Device Lot Number5726480102
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/28/2018
Is This a Reprocessed and Reused Single-Use Device?

Patient Treatment Data
Date Received: 03/15/2018 Patient Sequence Number: 1
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