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); Burning Sensation (2146); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On 04jan2019 a patient (pt) from (b)(6) reported via social media a diagnosis of corneal ulcer from going to the beach while wearing an acuvue oasys brand contact lens.The pt reported the event occurred years ago.The pt did not go into the ocean but reported as the tide rose, a drop of seawater went through the sunglasses and into the eye.The pt had symptoms of discomfort in the affected eye but continued to wear the suspect lens until arrival home.The pt reported the suspect lens was then removed and had a burning sensation in the affected eye when the pt tried to return to lens wear.The pt went to the eye care provider (ecp) who diagnosed the corneal ulcer.The pt did not return to contact lens (cls) wear for 4 months.The pt is currently wearing the 1-day oasys brand contact lenses without issue and the affected eye is fine.On 07jan2019 an email was received from the pt who reported the affected lot number is not available.The pt also reported the medication prescribed is unknown as it was long ago.On 09jan2019 the pt reported the event occurred in (b)(6) 2013 and the diagnosis was a corneal ulcer od.The treating ecp information is unknown.The pt was prescribed antibiotic and lubricating eye drops which were used three times a day.No additional information has been received.The lot number is unknown.The suspect od lens was discarded.This event is being reported as a worst-case event as the diagnosis and treatment were unable to be verified by the pts treating ecp.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: 8282695
• MDR Text Key: 134257567
• Report Number: 1057985-2019-00014
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): Y
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2019
• 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: 01/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention