MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. AQUA SOFT DAILY CONTACT LENS; LENSES, SOFT CONTACT, DAILY WEAR

Model Number PWR: -2.25 BC: 8.8 DIA: 14.1

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

Patient Problems Corneal Abrasion (1789); Edema (1820); Inflammation (1932); Pain (1994); Visual Impairment (2138); Discomfort (2330); Injury (2348)

Event Date 01/07/2020

Event Type  Injury  

Event Description

I have been using 1-800-contacts for years to order my contacts that are prescribed by my optometrist.I use 1-day acuvue moist pwr: -2.25 bc: 8.5 dia: 14.2.I see an optometrist yearly and have had the same prescription for years.I received a sample box of 1-800-contacts brand aquasoft dailies to try in my last shipment of accuvue moist dailies.The aquasoft contacts i was given was the same prescription that i use: -2.25 left eye and -2.50 right eye.I tried the sample contact briefly.I got an email with an offer for a free 2 wk supply if i ordered more.I ordered two more wks just to try them out (i normally order 90 day supply at once).On tuesday, (b)(6) 2020 i put the contacts in my eyes before work at 6:30 in the morning.I had some discomfort all day with a "sandy feeling" while at work.I did not have my glasses or another pair of contacts on me so i left them in because i can't work or see without contacts / glasses.At 4:00 pm i took the contacts out and discarded them.I put on my glasses.I then progressively started having more and more pain increasing to severe pain.The pain was so severe, i was unable to open my eye.Had severe watering, and edema of my eyelid.At this point inspected the packaging of the aquasoft contact i used and noticed it had different "bc and dia" measurements.I immediately called the company and notified them of my findings and my symptoms.I notified them i was going to emergency room due to severe pain.I went to the (b)(6) emergency room at 9:45 pm and was there until approx 2:00 on (b)(6) 2020.I was diagnosed with a large corneal abrasion(s) on the left eye and bilateral iritis.I was given optical antibiotic drops, vigamox.On (b)(6) 2020 at 11:15 am, i was seen by an ophthalmologist, dr (b)(6) as referred by the pa-c at (b)(6).I had an eye exam and a retinal scan.He confirmed the large corneal abrasion, continued the antibiotic drops, and was instructed to f/u with an ophthalmologist in 1 wk.I contacted the company, once again, to give them an update on my status.I was told i would be given a call back by their "health dept." i did not receive a call.On (b)(6) 2020 i woke up with large decrease vision in my left eye and dizziness from the vision charge.I called dr (b)(6), an ophthalmologist and was immediately seen in her office.I was given a fluorescein scan and thorough eye exam.It was confirmed i had severe corneal abrasions, severe inflammation, and decreased vision in my left eye.Dr (b)(6) increased the frequency of the drops, preservative free rewetting drops and added an antibiotic ointment to be used nightly.I was notified to f/u this week.I called 1-800-contacts again to provide them with an update and also that i have not spoken to anyone from the company regarding my adverse event / serious injury.I phoned dr (b)(6) on sunday (b)(6) that my vision in my left eye was not improving.I was seen in dr (b)(6) office the next day on (b)(6) at 4:00 pm to assess the condition of my eye and vision.I am continuing the regimen of my drops, she added a steroid drop, and i am to continue the nightly antibiotic ointment.Dr (b)(6) informed me that my vision in my left eye may never improve and an injury of that nature can permanently change my prescription.In 4-6 wks she will assess what my new prescription will be following the injury.I was unable to drive from (b)(6).My fiance and i both missed work on (b)(6) due to my injury and i was able to work shortened hours remotely from home the remaining days.I still have not received a response from 1-800-contacts as promised.I am following up with dr (b)(6) on (b)(6) to f/u on condition of my eyes.My contact prescription is pwr: -2.25 bc: 8.5 dia: 14.2.The aqua soft contact.Pwr: -2.25 bc: 8.8 dia: 14.1.Fda safety report id# (b)(4).

• Brand Name: AQUA SOFT DAILY CONTACT LENS
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC.
• MDR Report Key: 9601687
• MDR Text Key: 176015786
• Report Number: MW5092347
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/05/2023
• Device Model Number: PWR: -2.25 BC: 8.8 DIA: 14.1
• Device Lot Number: 392000
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability