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

Catalog Number PH

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Corneal Ulcer (1796); Unspecified Infection (1930); Pain (1994); Red Eye(s) (2038); Corneal Infiltrates (2231)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2019 an email was received from a patient (pt) reported while wearing the acuvue oasys brand contact lenses, the pt was diagnosed with multiple ulcers in both eyes.The pt was prescribed an antibiotic/steroid eye drop and reported sensitivity to light and horrible pain in both eyes.On (b)(6) 2019 the pt reported about 6 months ago both eyes were getting red while wearing the suspect lenses.The pt removed the lenses thinking it was allergies.Pt then reported a sensitivity to light, wore glasses and the eyes became ok, so the pt resumed contact lens wear.The pt reported the symptoms returned which the pt contributed to allergies.The pt reported on a friday, the eyes became red while at work, the pt went home and laid in the dark due to the eye pain.The pt went to the eye care provider (ecp) the following monday and was diagnosed with corneal ulcers ou.Pt was prescribed tobramycin 1 drop qid for 1 week.The event date is 2018.On (b)(6) 2019 a call was placed to the pt's ecp and additional medical information was requested.On (b)(6) 2019 the pt¿s medical records were received: date of visit: (b)(6) 2018: chief complaint: pt presents with bouts of redness and light sensitivity for the past few weeks, comes and goes, worse when wearing cl¿s, has used optifree refresh drops, visine a ¿ helps a little, vision is also strained.Va: od: dva: 20/20; os: 20/20.Confrontation visual field od: confrontation fields are full to finger counting, os: confrontation fields are full to finger counting exam: lid: od: normal; os: normal.Conj: od: moderate injection; os: moderate injection.Cornea: od: infiltrates, several; os: infiltrates and ulcer, 3 superior close to limbus anterior chamber: od: normal depth, no cells or flare; os: normal depth, no cells or flare.Intraocular pressure: od: 18mmhg; os: 18mmhg.Assessment: unspecified corneal ulcer, bilateral.Plan: possibly from cl overwear.No dendrites seen today but will assess for growth in 2 days.Rtc in 2 days.No cl wear.Discard current cl¿s and care material.Tobrex 1 drop 4 times a day, both eyes, for 1 week.Prescriptions: tobradex 1 drop ophthalmic qid 1 drop, 4 times a day, both eye, duration: 1 week.Date of visit: (b)(6) 2018.Chief complaint: pt presents for follow-up on corneal ulcer.Pt reports compliance with eye drops.Va: od: dva: 20/20; os: dva: 20/20.Exam: conjunctiva: od: mild injection; os: mild injection.Cornea: od: 1 infiltrate left; os: 3 ulcers smaller than last time superior limbus.Anterior chamber: od: normal, no cells, no flare; os: normal, no cells, no flare intraocular pressure: od: 16mmhg; os: 16mmhg.Assessment: unspecified corneal ulcer, bilateral.Plan: continue tobradex 1 drop, both eyes for 5 more days, sunglasses when outdoors on trip; rtc (b)(6) 2018; at¿s as needed.On (b)(6) 2019 a call was placed to the pts treating ecp and additional medical information was provided: the ecp reported the pt was diagnosed with corneal ulcer ou; the corneal ulcers were peripheral, superior limbus, but treated as infectious.The pt did not return for the follow-up visit but was reported to be fine.The pt did not have any permanent injury and permanent loss of visual acuity.No additional medical information has been received.This report is for the pts od event.The event for the pts os will be submitted in a separate report.The suspect od lens 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 b00mjfx was produced under normal conditions.If any further relevant information is received, a supplemental report will be filed.

• Brand Name: ACUVUE OASYS
• Type of Device: LENSES, SOFT CONTACT, EXTENDED WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. ¿ US; 7500 centurion parkway; jacksonville FL
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 8307855
• MDR Text Key: 135151322
• Report Number: 1057985-2019-00017
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/01/2021
• Device Catalogue Number: PH
• Device Lot Number: B00MJFX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/08/2019
• Initial Date FDA Received: 02/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2016
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention