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 Corneal Ulcer (1796); Pain (1994); Red Eye(s) (2038); Swelling (2091); Excessive Tear Production (2235)

Event Date 12/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).

Event Description

On (b)(6) 2017 a patient (pt) from (b)(6) called to report while wearing the acuvue oasys for astigmatism brand contact lenses he/she was diagnosed with a corneal ulcer in the left eye on (b)(6) 2017.The pt was given trial lenses on (b)(6) 2017, but did not wear the lenses every day.Pt could only wear the lenses for a few hours.Pt experienced redness, tearing, swelling and pain that began on (b)(6) 2017.Pt went to the eye hospital and was diagnosed with corneal ulcer in the left eye.Pt was prescribed gentamycin eye drops every hour and returned for a follow-up visit the following day.Pt continued to use the eye drops every hour for one week in the left eye.Pt reported the left eye is still swollen and was advised he/she could have lost vision in the affected eye.Pt reported a follow-up visit scheduled for (b)(6) 2017 for ¿discharge¿.Pt reports being told by the optical that the lenses could be worn thirty times.Pt did not sleep in the lenses.Pt discarded the suspect lens and was unable to provide the name of the solution used to disinfect and store the lenses.On (b)(6) 2017 a call was placed to the optical and spoke with the contactologist who reported the pt came in with ¿issues¿ with an unknown brand of lenses.The contactologist reported the pt was given trial lenses for the oasys for astigmatism lenses and returned the next day and reported a diagnosis with corneal ulcer in the left eye.The lot number of the suspect lens was unknown.The solution the pt was using at the time of the reported as arlyte premium solution.On 02jan2018 a call was placed to the pts treating eye clinic for additional medical information.A representative reported the pt would have to present to the clinic and get the records.No medical information was provided.On (b)(6) 2018 an email was received from pt with additional information: -pt reported after finishing the treatment, after seven days the eye reddened again and pt was prescribed lopred biotic (loteprednol etabonate trobamycin) for seventy-two hours.Pt has a return appointment on (b)(6) 2018.On (b)(6) 2018 a call was placed to the pt and additional information was provided: pt reported redness seven days after the treatment and left eye treatment and has not returned to contact lens wear.Pt reported ecp advised the left eye corneal ulcer had not completely closed.Pt was prescribed lopred ophthalmic solution one drop every six hours for seventy-two hours.Pt has a return appointment on (b)(6) 2018.Pt to send medical records after the ecp visit.No additional medical information has been received.The lot number is unknown and the suspect lens was discarded.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 19jan2018 an email was received from the pt with additional information: an eye care provider (ecp) note dated (b)(6) 2017; ¿patient (pt) developed a left eye corneal ulcer caused by contact lens trauma on (b)(6)2017.After treatment of topical antibiotics, the pt was discharged, cured and without further consequence on (b)(6) 2017¿.A prescription reflects the pt was prescribed lopred biotic (prednisone and tobrymycin ophthalmic solution) pt had a follow-up appointment on monday, (b)(6) 2018 with ophthalmologist.No additional information was received.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

Additional information was received from the patient (pt) on (b)(6) 2018 who stated that she saw the eye care professional (ecp) on (b)(6) 2018 and was told her eyes were improving.The pt stated that she saw the ecp again at the beginning of february 2018 and was discharged and was instructed to never to wear any brand of contact lenses again.No additional medical information has been received.This report is for the os (left eye) event.Mdr 1057985-2018-00006 is for the od (right eye) event.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.

• 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: 7184271
• MDR Text Key: 97057668
• Report Number: 1057985-2018-00005
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 03/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: CYP
• Device Lot Number: UNK-CYP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/19/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 39 YR