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); Swelling (2091); Excessive Tear Production (2235)

Event Date 12/01/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2017 a patient (pt) from (b)(6) called to report while wearing the acuvue oasys for astigmatism brand contact lenses he/she experienced redness, tearing, swelling and pain that began on (b)(6) 2017.The pt was given trial lenses on (b)(6) 2017, but did not wear the lenses every day.Pt could only wear the lenses for a few hours.Pt went to the eye hospital and was diagnosed with a bacterial infection in the right eye.Pt was prescribed gentamycin eye drops every hour for three days.Pt returned for a follow-up visit the following day.Pt reported a follow-up visit scheduled for (b)(6) 2017 for ¿discharge¿.Pt reports being told by the optical that the lenses could be worn thirty times.Pt did not sleep in the lenses.Pt discarded the suspect lens and was unable to provide the name of the solution used to disinfect and store the lenses.On (b)(6) 2017 a call was placed to the optical and spoke with the contactologist who reported the pt came in with ¿issues¿ with an unknown brand of lenses.The contactologist reported the pt was given trial lenses for the oasys for astigmatism lenses.The lot number of the suspect lens was unknown.The solution the pt was using at the time of the reported as arlyte premium solution.On (b)(6) 2018 a call was placed to the pts treating eye clinic for additional medical information.A representative reported the pt would have to present to the clinic and get the records.No medical information was provided.On (b)(6) 2018 an email was received from pt with the medical summary from the eye care provider (ecp): - medical summary dated (b)(6) 2017: "pt developed a right eye corneal abscess caused by contact lens trauma on (b)(6) 2017.After treatment of topical antibiotics, the pt was discharged, cured and without further consequence on (b)(6) 2017." no additional medical information has been received.The lot number is unknown and the suspect lens was discarded.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.

Manufacturer Narrative

Additional information was received from the patient (pt) on (b)(6) 2018 who stated that she saw the eye care professional (ecp) on (b)(6) 2018 and was told her eyes were improving.The pt stated that she saw the ecp again at the beginning of february 2018 and was discharged and was instructed to never to wear any brand of contact lenses again.No additional medical information has been received.This report is for the od (right eye) event.Mdr 1057985-2018-00005 is for the os (left eye) event.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
• MDR Report Key: 7184279
• MDR Text Key: 97059227
• Report Number: 1057985-2018-00006
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 03/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: CYP
• Device Lot Number: UNK-CYP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/19/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 39 YR