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

Catalog Number PH

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

Patient Problems Bacterial Infection (1735); Conjunctivitis (1784); Red Eye(s) (2038); Discharge (2225)

Event Date 11/13/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter's phone number: (b)(6).

Event Description

On 27dec2019 a patient (pt) in mexico reported a diagnosis of bacterial conjunctivitis od while wearing the acuvue® oasys® brand contact lenses.The pt reported redness and ¿glaze¿ with a lens on the 2nd or 3rd day of wear.The pt went to an eye care provider (ecp) who prescribed ciprofloxacin eye drops every 4 hours for 7 days, contact lens rest, baby shampoo eye washes tid and warm compresses tid.The pt advised the os was fine, but the ecp advised the pt to treat the os with the prescribed antibiotics prophylactically.The pt returned to contact lens wear on (b)(6) 2019.The pt reported using opti-free solution to clean lenses.On 30dec2019 a call was placed to the pt who provided additional information: the pt reported initial confusion when reporting the date of the event.The pt advised the onset of symptoms began on (b)(6) 2019 and went to the ecp on (b)(6) 2019.The pt provided the medical report from the (b)(6) 2019 visit.Medical report dated 15nov2019: the pt reported to the ecp with od redness, burning sensation, ¿mucusy¿ discharge, foreign body sensation for 7 days.The pt treated with hot chamomile compresses.Exam od: visual acuity: 20/400; intraocular pressure: 12 mmhg; eyelids: slight secretion; conj: bulbar hyperemia 1+, tarsal papillaes; cornea: clear exam os: visual acuity: 20/40; intraocular pressure: 12 mmhg; eyelids: slight secretion; conj: bulbar hyperemia 1+, tarsal papillaes; cornea: clear impression: ou bacterial blepharoconjunctivitis plan: sophixin (cipro/dexamethasone) 1 drop every 4 hours for 5 days and stop; hyabak 1 drop every 6 hours ou continuous use; do not use contact lens for the 5 days of treatment and use 1 new pair of lenses at the end of treatment; wash lashes with baby shampoo.Multiple calls were placed to the pts treating ecp for additional medical information, but nothing additional was received.The lot number for the os is unknown.The suspect os contact lens was discarded.No additional investigation can be conducted.This report is for the pts os event.The report for the pts od event will be submitted in a separate report.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. ¿ USA; 7500 centurion parkway; jacksonville FL
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 9588810
• MDR Text Key: 187462308
• Report Number: 1057985-2020-00007
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): Y
• Reporter Country Code: MX
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: PH
• Device Lot Number: UNK-PH
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 27 YR