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

Catalog Number CYP

Device Problem No Apparent Adverse Event (3189)

Patient Problems Bacterial Infection (1735); Pain (1994); Red Eye(s) (2038)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2017 our affiliate in (b)(6) received an email from a patient (pt) who reported eye pain (affected eye not provided), sought medical attention, and purchased over-the-counter eye drops.The pt reported the ¿vision was also less visible¿.On 06nov2017 and 09nov2017 the affiliate attempted to reach the pt by telephone, but they were unable to reach the pt.On 25nov2017 the affiliate placed a call to the pt and additional information was received: the pt reported the suspect product is acuvue oasys for astigmatism brand contact lenses.The pt reported the event occurred in (b)(6) 2017 and the affected eye is the left eye.The pt went to an eye care provider (ecp) as redness persisted after the suspect lens was removed.The pt reported that the ecp ¿assumed that bacteria might have come into the eye¿.The pt was prescribed sanbetason ophthalmic, otorhinologic solution and cravit ophthalmic solution.The pt reported there was no instructions to discontinue lens wear or return to the clinic.Currently, the pt has no left eye symptoms.The suspect lens was discarded.No additional medical information was received and no additional medical information is expected.This left eye event will be reported as a worst-case event as the diagnosis was not verified by the pts treating ecp.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 b00mlnb 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 FOR ASTIGMATISM
• 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: 7135238
• MDR Text Key: 95404115
• Report Number: 1057985-2017-00145
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 11/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/01/2022
• Device Catalogue Number: CYP
• Device Lot Number: B00MLNB
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2017
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 52