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

Catalog Number PH

Device Problem No Apparent Adverse Event (3189)

Patient Problems Foreign Body Sensation in Eye (1869); Acanthameba Keratitis (1945); Pain (1994); Red Eye(s) (2038); Swelling (2091); Burning Sensation (2146)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2018 a patient (pt) in (b)(6) was diagnosed with keratitis in both eyes while wearing the acuvue oasys brand contact lens.The pt reported a ¿strong irritation¿ and redness while wearing the suspect lenses and went to an ophthalmologist who provided the diagnosis.The eye care provider (ecp) prescribed flutinol for a month.On (b)(6) 2018 a call was placed to the pt and additional information was obtained: pt reported that the ou symptoms of itching, burning sensation, redness, foreign body sensation, pain, and swelling began in (b)(6) 2018.The os symptoms were worse than the od.Pt reported on removal of the suspect lenses, both eyes were better within 4 days.Pt reported the ecp visit in (b)(6) 2018 and diagnosed with ou keratitis.The ecp prescribed flutinol q 4 hours for 7 days, then every 8 hours for 7 days, then every 12 hours for 7 days.Pt is no longer using the medication.The pt was also prescribed an over the counter eye drop, but it was not purchased.Pt reported that the ecp advised it was ok to return to contact lens wear 3 days after the treatment began.The pt attempted to return to lens wear, but both eyes became red and painful.Pt reported a follow-up visit with the ecp after 2 weeks and ecp advised the pt had keratitis because the pt insisted on wearing the lenses.The pt reported the ecp advised the pt to change the disinfecting solution and ¿perhaps use another brand lens if that does not help¿.Pt has not returned to the ecp and reports the eyes are ok now.Pt is currently wearing glasses.The pt reported using ultrasept disinfecting solution.Pt reports a contact lens wear schedule of 1 month with daily use.On (b)(6) 2018 a call was placed to the pts treating ecp and additional medical information was requested, but ecp was unable to locate pt in records.On (b)(6) 2018 a call was placed to the pt to confirm the ecp contact information.Pt went to an ophthalmic urgent care clinic and was unable to provide the contact information.Pt has not returned to contact lens wear.On (b)(6) 2018 an email was received from the pt with the following attachments: the ecp contact information was provided; attachment, not dated stated ¿renu sensitive, clean lenses 1-2 x daily.2nd attempt change lens to sealed av2.3rd attempt purevision2/oasys¿.Ecp prescription dated (b)(6) 2018 for flutinol 1 drop q 4 hours for 7 days, then q 8 hours for 7 days, then q 12 hours for 7 days, then qd for 7 days.Ecp prescription, not dated for flutinol 1 drop every 12 hours for 7 days; with lenses: fresh tears, 1 drop q 8 hours for 7 days.On (b)(6) 2018 a call was placed to the pts ecp and additional information was provided: a representative reported the ecp is no longer employed at the clinic; the pt visit was on (b)(6) 2018 with complaints of swelling and pain ou.Pt was prescribed flutinol q 12 hours.The representative reported no diagnosis was noted on the pt¿s chart and there was no mention of when the pt could return to contact lens wear.No additional pt visits were noted.No additional information was provided.No additional information has been received.The suspect product was discarded by the pt.This report is being submitted for the pts od event.The event for the pts os will be submitted in a separate report.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 l0033fh 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 (b)(6) 2018 a call was placed to the patient (pt) who provided additional information: -pt has not returned to contact lens wear.Pt will provide additional information on return to the eye care provider (ecp) regarding the approval to return to lens wear.No additional information was provided.This report is being submitted for the pts od event.The event for the pts os will be submitted in a separate report.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.

• Brand Name: ACUVUE OASYS
• Type of Device: LENSES, SOFT CONTACT, EXTENDED WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND; one technological park plassey; limerick ; EI
• MDR Report Key: 7626756
• MDR Text Key: 111988028
• Report Number: 9617710-2018-05040
• 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,health profe
• Type of Report: Initial,Followup
• Report Date: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/01/2022
• Device Catalogue Number: PH
• Device Lot Number: L0033FH
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/25/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention