MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ US ACUVUE OASYS FOR ASTIGMATISM; LENSES, SOFT CONTACT, EXTENDED WEAR

Catalog Number CYP

Device Problem No Apparent Adverse Event (3189)

Patient Problems Bacterial Infection (1735); Corneal Scar (1793); Corneal Ulcer (1796); Pain (1994); Loss of Vision (2139); Discharge (2225)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter's phone number: (b)(6).

Event Description

On (b)(6) 2018, a patient (pt) in (b)(6) sent an email to report being diagnosed with a corneal ulcer in the left eye (os) while wearing acuvue oasys for astigmatism contact lenses (cls).The pt reported the ulcer has ¿permanently altered the vision through scarring¿ and has been treated for the past 3 weeks for an ¿aggressive bacteria¿.Information received from the pt has not yet been confirmed with the treating eye doctor.On (b)(6) 2018 the following information was received: the pt replaces the lenses every 2 weeks and stores cls in hycare multi-purpose solution.The pt does not sleep/swim/shower in lenses.On (b)(6) 2018: pt inserted a new pair of cls (the second lens from the pack).During the evening, the eye started to become sensitive to light and uncomfortable and felt ¿like it wanted to close¿.The cl was removed once the pt was at home.On (b)(6) 2018: pt woke in ¿horrendous pain¿ and was very light sensitive.The pt went to the hospital and diagnosed with a ¿scratch¿ and prescribed chloramphenicol eye drops for 5 days.On (b)(6) 2018: pt woke in even more pain than the previous day.The pt¿s light sensitivity had increased and the eye was closed and ¿gunky¿.The pt lifted the lid to look at the eye and described ¿the pupil looked white¿.The pt went back to the hospital and referred to an ophthalmologist.The pt described vision as ¿very poor¿ and could not see any letters on the chart and could only see shapes moving.The ophthalmologist diagnosed a corneal ulcer, 3.4 mm in diameter, located slightly temporally.Scraping of the ulcer was taken to check bacteria.Prescribed: chloramphenicol drops, exocin drops (hourly, including throughout the night for 4 days) and mydrilate (to dilate the pupil).On (b)(6) 2018: pt had a follow-up with the ophthalmologist and was prescribed oral antibiotics (co-amoxiclav) for use 4 x daily.On (b)(6) 2018: the ulcer had decreased in size to 3mm.The pt was prescribed exocin reduced to every 2 hours during the day only.The pt¿s va was approx.6/60.On (b)(6) 2018: the culture revealed the primary bacteria was pseudomonas and streptococcus; co-amoxiclav tablets were discontinued and pt prescribed ciprofloxacin.The pt was advised to continue with exocin every 2 hours and to continue with chloramphenicol.The ulcer size was 3mm.On (b)(6) 2018: the ulcer size was reported at 3mm.The pt was advised to reduce exocin to every 3 hours and continue with chloramphenicol.On (b)(6) 2018: the ulcer had decreased in size to 2.6mm.The antibiotics were reduced and predsol eye drops were added to lessen scarring.On (b)(6) 2018: the ulcer was reported to be decreasing in size, described by the ophthalmologist as size of a needle pin.The pt¿s reported the va was much better, but was hazy.Pt was also experiencing a lot of glare.The pt was advised to stop taking oral antibiotics, but to continue with predsol and chloramphenicol.On (b)(6) 2018: the pt reported a follow-up appointment on (b)(6) 2018.The ophthalmologist told the pt that there is no longer any active sign of infection and to taper off the chloramphenicol drops.The pt was instructed to continue using the predsol drops for 2 months to try and reduce scarring.The pt could read 4 lines down on the chart while wearing glasses and described vision as hazy with a lot of glare, particularly at night.The pt was advised to have another follow-up exam once the drops were completed as the prescription may have changed.The ophthalmologist also informed the pt that vision is unlikely to improve further and the only option is laser surgery.Pt reports the scar currently measures 2.5mm.All information received has been reported by the pt.We have been unable to confirm the pt diagnosis and treatment with the pts treating physician.A medical release form was sent for additional medical information from the pt's treating eye care provider, but it has not yet been returned by the pt.No additional information was received.The suspect product is not available for return, as it was 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 b00pd5x 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) 2019 the patient provided additional information.The patient reported being discharged from the hospital, is currently under the care of an ecp and the os vision is permanently affected and can only see the large letters on the chart.The pt has not returned to cl wear.No further information was provided.If any further relevant information is received, a supplemental report will be filed.

• Brand Name: ACUVUE OASYS FOR ASTIGMATISM
• Type of Device: LENSES, SOFT CONTACT, EXTENDED WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. ¿ US; 7500 centurion parkway; jacksonville FL
• MDR Report Key: 7512254
• MDR Text Key: 108227067
• Report Number: 1057985-2018-00071
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): Y
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Type of Report: Initial,Followup
• Report Date: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/01/2022
• Device Catalogue Number: CYP
• Device Lot Number: B00PD5X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/08/2019
• Patient Sequence Number: 1
• Treatment: HYCARE MULTI-PURPOSE SOLUTION
• Patient Outcome(s): Other; Required Intervention; Disability