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

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.

• Brand Name: 1-DAY ACUVUE MOIST
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND; one technological park plassey; limerick ; EI
• MDR Report Key: 7342939
• MDR Text Key: 102580206
• Report Number: 9617710-2018-05026
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• PMA/PMN Number: N18033
• Number of Events Reported: 1
• 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 Received: 03/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/01/2022
• Device Catalogue Number: 1DM
• Device Lot Number: 5726480102
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/28/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention