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

Catalog Number PH

Device Problem No Apparent Adverse Event (3189)

Patient Problem Corneal Scar (1793)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2018 while documenting a current event with a patient (pt) who provided medical records, it was noted the pt had an od temporal scar.On 09jan2018 a call was received from the pts treating ecp and additional information was provided: the ecp reported the scar is from a previous unknown event which is noted in the pts 2016 and 2017 eye exams.The scar was not noted in 2014 or 2015 and the pt was not seen for a medical event at the office.The pt has always worn an acuvue product.Medical records received from the pts ecp: date of visit: (b)(6) 2017, slit lamp, cornea: od scar, comments: inferior temporal scar od.Date of visit: (b)(6) 2017, slit lamp, cornea: od scar, comment: inferior temporal scar od.On 09jan2018 a call was placed to the pt and additional information was provided: the pt was not aware of the corneal scar until the ecp advised the pt.Pt does not recall a previous event and did not seek medical attention from a different ecp.The pt has always worn acuvue oasys brand contact lenses.The lot number of the suspect product is unknown and the suspect lens is not available.The event date is unknown.No additional medical information has been received and no additional medical information is expected.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. ¿ US; 7500 centurion parkway; jacksonville FL
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 7236858
• MDR Text Key: 98863408
• Report Number: 1057985-2018-00011
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• 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: 01/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2018
• 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: 01/08/2018
• 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