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 Corneal Ulcer (1796); Itching Sensation (1943); Red Eye(s) (2038)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2017 a patient (pt) from (b)(6) called to report while wearing the acuvue oasys brand contact lenses he/she experienced redness after four days of wear.The pt reported he/she didn¿t notice anything unusual after removing the suspect lens.The pt reported the left eye was better the following day.The pt inserted the suspect lens and began to experience redness and itching immediately on insertion.The pt reported he/she is a new wearer of the oasys brand lenses.The pt went to an eye care provider and was diagnosed with a corneal ulcer in the left eye.The event date was reported as (b)(6) 2017.The pt was prescribed vigadexa 1 drop every two to four hours for ten days.The pt reported a monthly replacement schedule and did not sleep in the lenses.The pt reported the left eye was better and has not tried to wear another contact lens.On (b)(6) 2017 a call was placed to the pt to obtain the treating ecp¿s contact information, but the pt did not have the ecp¿s phone number.No additional information was provided.On 07dec2017 an email was received from the affiliate in (b)(6) after speaking with the pts treating ecp.Additional information was provided as follows: event date: (b)(6) 2016.The pt presented in (b)(6) 2016 and was diagnosed with a corneal ulcer.Pt was prescribed vigadexa for seven days, (b)(6) 2016 to (b)(6) 2016 and the corneal ulcer resolved with no permanent damage.The ecp allowed the pt to return to contact lens wear.No additional medical information was received.The pt reported the suspect lens was discarded.No additional medical information was received and no additional medical information is expected.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 l002vjh 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: 7139830
• MDR Text Key: 95599746
• Report Number: 9617710-2017-05077
• 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: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/01/2021
• Device Catalogue Number: PH
• Device Lot Number: L002VJH
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2016
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 30