MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. JOHNSON AND JOHNSON ACUVUE MOIST DAILY CONTACT LENSES; LENSES, SOFT CONTACT, DAILY WEAR

Model Number D -10.0 BC 8.5

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dry Eye(s) (1814); Eye Injury (1845); Red Eye(s) (2038); Increased Sensitivity (2065)

Event Date 11/20/2019

Event Type  Injury  

Event Description

Summary of the facts i am short sighted with dioptres -11 in both eyes.I have been wearing daily contact lenses 1-day acuview moist -10.00 bc 8.5 from johnson and johnson ('j&j') for the past three years.I have been wearing contact lenses, hard lenses and soft lenses of different strengths for the past 30 years.I never had any problems nor issues with the lenses.I am wearing the lenses on average 12 hours per day.On (b)(6) 2019 i purchased my daily lenses from a (b)(6) online company "(b)(6)".I purchased some of my lenses from this company in the past and had no issues.I started wearing the said lenses towards end of the (b)(6) 2019.Soon after the area around my irises became red.As far as i can remember there were no other symptoms in the beginning.Initially, i linked the redness to some kind of an allergic reaction.I then begun withdrawing several types of foods, tried to avoid eye make-up and all types of other substances.I also tried using lubrication drops.Despite all the measures i took there was no improvement.The redness around my eyes worsened and, on (b)(6) 2019, i visited my gp.I arrived at the gp appointment without contact lenses to enable the gp to examine my eyes.The gp said that the redness could be associated with the wearing of the contact lenses.She suggested to refrain from wearing the lenses, use lubricant and advised me to take eye drops called chloramphenicol.The gp added that if there is no improvement after a week, i should see an eye specialist.After a week of following the gp's advice, my eyes were still very red and there was no improvement.On the (b)(6) 2019, i panicked and referred myself to the (b)(6) hospital, to the a& e department.At that point, i was concerned and upset.The nurse who examined me told me that the corneas of both of my eyes were scratched and that if i continued to wear contact lenses, i was at real risk of losing my eyesight.When he heard that i usually wear the contact lenses for an average of 12 hours per day, he said that 'lenses over wear' may be the cause of the scratches.The nurse suggested not to wear the contact lenses for two weeks and prescribed antibiotic drops.Being told i could lose my eyesight was extremely upsetting.As someone with such a high prescription, i am very concerned about my eyesight, and the thought of losing it is unbearable.Liability the reason why i am alleging fault is the following: after a period of a few weeks of not wearing the said lenses, the symptoms alleviated so i decided to wear another pair of acuview moist on (b)(6) ((b)(6) 2019).After ca.Two hours of wearing them, i felt pain and my eyes felt very sensitive.I rushed home and noticed that my eyes were very red again.I assumed that my eyes have not completely recovered and decided to give them another break.Two weeks later i wore another pair of acuview moist.Again, after a couple of hours of using them my eyes turned red.Only then i realised that the problem was directly caused by the contact lenses and not by overwear as it was suggested to me.I began researching for the cause and found out that johnson & johnson made a number of recalls since september 2019 (e.G., in (b)(6), the us, (b)(6)) to acuview moist daily lenses.However, the recalls affected other dioptres (-3.5 and -6.00).The reason for the recalls was the presence of particles in the contact lenses.The described symptoms were very similar to those i experienced.Injuries for a period of two months, i suffered severe redness to my eyes, dry eyes, and sensitivity to light.It was painful to be exposed to sunlight or even indoor lights.During the entire period i had to wear my glasses the whole day long.Due to my large prescription, my glasses were very heavy on my nose, injured the back of my ears, and gave me constant headaches.It was very hard for me to be exposed to light and or see in the dark.Fda safety report id# (b)(4).

• Brand Name: JOHNSON AND JOHNSON ACUVUE MOIST DAILY CONTACT LENSES
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC.
• MDR Report Key: 10579613
• MDR Text Key: 208588359
• Report Number: MW5096835
• Device Sequence Number: 1
• Product Code: LPL
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: D -10.0 BC 8.5
• Device Lot Number: 3826980107C
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Weight: 55