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 Bacterial Infection (1735); Corneal Ulcer (1796); Irritation (1941); Itching Sensation (1943); Red Eye(s) (2038); Discharge (2225); Excessive Tear Production (2235)

Event Date 10/23/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

On (b)(6) 2017 a patient (pt) from (b)(6) called to report right eye redness, itching and irritation after ten days of wearing the acuvue oasys brand contact lenses in (b)(6) 2017 as the lens tore while during wear.The pt reporting the eye was red, irritated and tearing, but reported the right eye is okay now.Pt went to the eye care provider (ecp) who confirmed ¿bacteria.¿ pt was prescribed zymar xd eye drops every two hours for two weeks.Pt reported at the end of the treatment the ecp prescribed ster md one drop in the morning and one drop at night before bed.Pt reported daily ecp visits for one week.The pt reported the ecp advised the pt to discard the box of lenses.The suspect lens was also discarded.The pt is to schedule a return visit next month with ecp and will ask if the pt can return to contact lens wear.Pt reported wearing the oasys brand contact lenses for over ten years.Pt used renu multi-purpose solution to disinfect the lenses.Replacement schedule was reported as monthly with daily use.Pt is currently wearing glasses.On (b)(6) 2017 a call was placed to the pt and additional information was obtained: pt reported first ecp visit was on (b)(6) 2017 and reports several f/u visits.Pt reported od itching and continued to wear the suspect lens all day despite symptoms.Pt reported after removing the suspect lens, it was torn.Pt inserted a new contact lens the following morning and consulted with the ecp.Pt reported right eye photophobia and discharge.Pt reported the right eye was better after 1.5 months.Pt reported once the drainage stopped, the pt had a ¿basin¿ like spot in the was better with treatment.Pt reported he/she has not returned to contact lens wear and will call ecp to set a fu appointment.On (b)(6) 2018 the pt sent an email with an ecp note and treatment: ecp prescription dated (b)(6) 2017 ster md drops use 1 drop every morning and evening; zymar xd drops use 1 drop every 3 hours until friday; saturday start every 4 hours, then wednesday every 6 hours.Ecp prescription dated (b)(6) 2017 zymar xd drops, use 1 drop on right eye every 2 hours.Ecp excuse note dated (b)(6) 2017; should stay off work on (b)(6) 2017.Ecp excuse note dated (b)(6) 2017; should stay away from work for 3 more days.On (b)(6) 2017 a call was placed to the pts treating ecp¿s office requesting additional medical information.Spoke with an ecp representative who requested a return call in the afternoon.On (b)(6) 2018 a call was placed to the pts treating ecp and a representative provided additional information: date of visit: (b)(6) 2017, pt presented with redness and secretion; ulcer, od lesion.Requested a return call in the afternoon to speak with the ecp for additional medical information.On (b)(6) 2018 a return call was placed to the pts treating ecp and additional information was provided: ecp reported diagnosis of od bacterial corneal ulcer, located peripheral superior cornea @ 10:00; pt last visit was (b)(6) 2017 and a small scar was present; pt has not returned for f/u visit after treatment, therefore pt has not been released to return to contact lens wear.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 l0033m2 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.

• 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
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 7207775
• MDR Text Key: 97856477
• Report Number: 9617710-2018-05005
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• 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: L0033M2
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2017
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 32