MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ US ACUVUE OASYS1 DAY WITH HYDRALUXE TECHNOLOGY; LENSES, SOFT CONTACT

Catalog Number TSP

Device Problem No Apparent Adverse Event (3189)

Patient Problems Corneal Ulcer (1796); Irritation (1941); Keratitis (1944); Pain (1994); Red Eye(s) (2038); Discomfort (2330)

Event Date 05/16/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(4).

Event Description

On (b)(6) 2018, a patient (pt) from the (b)(6) emailed to report a ¿possible adverse event¿ while wearing acuvue oasys®1 day with hydraluxe¿ technology contact lenses (cls).On (b)(6) 2018, the pt was contacted and provided the following: the pt reported presenting to a hospital and receiving treatment for an ulcer.The pt reported being advised to discontinue lens wear and was prescribed exocin, initially 1 drop every hour for 4 days, then 1 drop every 2 hours, and finally 1 drop every 4 hours.On (b)(6) 2018, the pt was contacted and provided additional information: the pt reported that on (b)(6) 2018, the lens was removed from the right eye (od) and immediately experienced discomfort.Pt discarded the suspect lens.On (b)(6) 2018, the pt reported experiencing a sore, photophobic, and red eye od.The pt reported the vision being slightly reduced and did not insert any lenses.The pt presented to an eye care provider (ecp) who advised the pt to go to a hospital.The pt reported presenting to the hospital where the pt was diagnosed with an od superior ulcer (size unknown).The pt was prescribed exocin to be used every 2 hours during the day.Pt presented to the hospital for f/u on the following dates: on (b)(6) 2018: pt was advised the ulcer had not improved and to increase the exocin eye drops to every hour while awake.On (b)(6) 2018: pt was advised the ulcer was improving and to reduce the exocin eye drops to every 2 hours while awake.On (b)(6) 2018: pt was advised to reduce the exocin eye drops to every 4 hours while awake.Pt advised to schedule a follow-up appointment with the ecp in 2 weeks before returning to lens wear.Pt reported the eye is ¿comfortable, white and vision is back to normal¿.Additional medical information was requested.No additional medical information has been received.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 5621760102 was produced under normal conditions.If any further relevant information is received, a supplemental report will be filed.Serious reportable event trends are reviewed quarterly in franchise management review meetings.

Manufacturer Narrative

On 11sep2018 the patient¿s (pt.) medical records were received with additional information: -(b)(6) 2018 hospital visit date: exam: contact lens (cl) related keratitis right eye (od); a/c quiet; od felt scratchy, removed contact lens; symptoms worse; redness, photophobia; visual acuity (va): 6/5 impression: "? contact lens related keratitis"; cl wearer, soft daily disp.Management: pt to return in 1 day; prescribed exocin od q2 h -(b)(6) 2018 follow-up (fu) visit: fu for: corneal ulcer od; healing ulcer; symptoms better than friday.Exam: anterior chamber: deep, no cells, no flare; va od: 6/6-1; impression: od healing ulcer; management: continue exocin hourly x 1 day, then q 2 h; pt to return on tuesday; rx given for exocin.-(b)(6) 2018 fu visit: fu: od corneal ulcer; current rx: exocin q2 h; no cl wear exam od: minimal surrounding edema; anterior chamber: deep, no cells, no flare; conjunctiva: white; va: 6/6 impression: od corneal ulcer, stable management: continue treatment; no cl wear.-(b)(6) 2018 fu visit: fu: od corneal ulcer; current rx: exocin; symptoms better exam: healed ulcer; va: 6/6; impression: continue with exocin qd for 2 weeks.Management: discharged to optician.No additional medical information was received.No additional medical information is expected.If any further relevant information is received, a supplemental report will be filed.Serious reportable event trends are reviewed quarterly in franchise management review meetings.Code 1944 - keratitis.Code 1941 - irritation.

• Brand Name: ACUVUE OASYS1 DAY WITH HYDRALUXE TECHNOLOGY
• Type of Device: LENSES, SOFT CONTACT
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. ¿ US; 7500 centurion parkway; jacksonville FL
• MDR Report Key: 7632491
• MDR Text Key: 112144844
• Report Number: 1057985-2018-00084
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): Y
• PMA/PMN Number: K042275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/01/2020
• Device Catalogue Number: TSP
• Device Lot Number: 5621760102
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/11/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 58 DA