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 Scar (1793); Corneal Ulcer (1796); Irritation (1941); Pain (1994); Red Eye(s) (2038); Swelling (2091); Blurred Vision (2137); Burning Sensation (2146); Discharge (2225); Excessive Tear Production (2235); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

Initial reporter's phone number: (b)(6).

Event Description

On 17nov2020 a patient (pt) in (b)(6) reported a diagnosis of od corneal ulcer while wearing the acuvue® oasys® brand contact lenses (cls).The pt experienced discomfort, redness and irritation in (b)(6) 2020 after a period of wearing the suspect cls.The pt continued to wear the od suspect lens as the discomfort continued.On (b)(6) 2020, the pt reported od irritation, redness, burning, discharge and noticed a ¿white spot¿ on the eye.On (b)(6) 2020 the pt went to an eye care provider (ecp) who diagnosed the od corneal ulcer at 5 o¿clock.The pt was prescribed vigamox every 2 hours for the first day, then every three hours on the return ecp visit on (b)(6) 2020.The pt was also prescribed hyabak lubricating drops every six hours.The pt is currently experiencing photophobia, redness, tearing, discharge, burning sensation, and blurry vision.The pt also advised the ¿white spot is becoming larger¿.The pt reported a contact lens replacement schedule every 2-3 months and only wears lenses on the weekend.On 19nov2020 a call was placed to the pt who provided additional information.The pt returned to see the ecp on (b)(6) 2020 and advised to continue vigamox every 2 hours and return on (b)(6) 2020.On (b)(6) 2020 the pt consulted a cornea specialist who changed the vigamox to every 3 hours and added a corticosteroid eye drop (name of the eye drop was not provided) once daily until the return visit on (b)(6) 2020.The pt reported the od is no longer painful but continues to experience photophobia and irritation.The pt will get a medical report on the (b)(6) 2020 return appointment.On 20nov2020 an email was received from the pt with a prescription dated 16nov2020 for vigamox 1 drop od every two hours today and after tomorrow, every three hours for seven to ten days.Hyabak 1 drop every six hours od until finished.The pt also provided a prescription dated 18nov2020 for predmild 1 drop once daily.On 23nov2020 a call was placed to the pt¿s initial treating ecp for additional medical information.A representative reported the pts chart indicated an od corneal ulcer at 7 o¿clock.The last visit was on (b)(6) 2020.The representative advised that the follow-up visits may not have been documented.On 02dec2020 a call was placed to the pt who provided additional information.The pt returned to see the corneal specialist on (b)(6) 2020, who advised the corneal ulcer is healing.The vigamox was changed to 3 times daily and predmild to be used daily until (b)(6) 2020, then discontinue all medication.The ecp requested the pt to return for follow-up visit in 15 days to evaluation the corneal ulcer for ¿scarring and possible laser for scar removal.¿ the pt reported the od is better, but still a little swollen and vision is still a little blurry.Multiple attempts have been made to the pt, the initial treating ecp, and corneal specialist to obtain additional medical information.No additional information was provided.No additional medical information was provided.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 b00rpq3 was produced under normal conditions.The suspect od lens was requested for return for evaluation, but it has not yet been received.If any further relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

On (b)(6)2020 a call was placed to the patient (pt) who reported a follow-up appointment (date not provided) with the eye care provider (ecp).The ecp advised the pt has a small scar on the od.No additional treatment was prescribed.The ecp will evaluate the od scar in (b)(6) 2021 for a refractive laser surgery visit.The ecp will laser the od scar at that time.The pt will no longer wear contact lenses.The pt is currently wearing glasses.No additional medical information was provided.If any further relevant information is received, a supplemental report will be filed.Section h ¿ 6: code 1793 ¿ corneal scar.

• 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
• MDR Report Key: 10996293
• MDR Text Key: 221463050
• Report Number: 1057985-2020-00073
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): Y
• 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: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/01/2023
• Device Catalogue Number: PH
• Device Lot Number: B00RPQ3
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/16/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention