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

Catalog Number PH

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dry Eye(s) (1814); Irritation (1941); Keratitis (1944); Pain (1994); Red Eye(s) (2038); Blurred Vision (2137); Burning Sensation (2146)

Event Date 06/13/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

On (b)(6) 2019 a patient (pt) in (b)(6) sent an email to report ¿my eye is on fire¿ on the 2nd day of wearing an acuvue oasys brand contact lens.The pt reported the lens was only worn for a few hours on (b)(6) 2019 and stored in solution (name of solution not provided).On the following day, the pt only used the suspect lens for 5 hours and began to experience irritation.The pt removed the suspect lens and the eye is ¿on fire.¿ on (b)(6) 2019 a call was placed to the pt and additional information was provided.Pt reported redness, burning and irritation after 4 hours of wear on (b)(6) 2019, the 2nd day of wearing the os suspect contact lens.The pt reported the eye was red and irritated on removal of the suspect os contact lens and the pt used vigamox drops previously prescribed.Pt reported the os symptoms didn¿t improve and pt visited the eye care provider (ecp) on (b)(6) 2019.The pt was advised by the ecp that the os was ¿very irritated¿ and due to the pain the ecp instilled medication in the os and placed an eye patch for 24 hours.The pt returned to the ecp after 12 hours due to the pain.At that visit, eye drops and analgesic drops were placed in the os.A new eye patch was placed over the os and the pt was advised to keep the eye patch in place for 24 hours and return for a follow-up visit.The pt reported the eye patch was worn for 36 hours.On (b)(6) 2019 the pt returned to the ecp and was prescribed vigamox every 3 hours and hyabak every 1 hour until the return visit on (b)(6) 2019.The ecp advised there ¿could be an ulcer at the superior part of eye.¿ the ecp advised the pt that the lenses are causing lack of lubrication causing symptoms.The pt has a return visit to the ecp today ((b)(6) 2019) and will try to obtain the medical report.The pt reported the os vision ¿decreased initially and it is slowly returning to normal.¿ pt advised the pain and redness have resolved, but os vision remains a ¿little blurry.¿ the pt reports daily lens wear with a monthly replacement schedule.The pt uses opti-free to disinfect the lenses.On (b)(6) 2019 a call was placed to the pt and additional information was provided.Pt reported a return visit to the ecp (date not provided).The os cornea was not completely healed.Pt was advised to continue the vigamox q 6 hours and hyabak q 1 hour.Pt has a return visit to the ecp today.Pt reported the ecp provided a statement with diagnosis, ¿frame of corneal keratitis due to misuse of contact lens.¿ pt reported it was not a corneal ulcer because it was a ¿mild case.¿ on (b)(6) 2019 an email was received from the pt the following attachments.A prescription dated (b)(6) 2019 for hyabak, hylogel, or optive 1 drop os every hour; vigamox 1 drop every 3 hours until return.Ecp statement dated (b)(6) 2019 states, ¿pt in follow-up in the emergency room with corneal keratitis due to improper use of contact lens in the left eye.At present, referring to improvement of the use of topical antibiotic and lubricant.¿ prescription dated (b)(6) 2019 for hyabak, hylogel optive or hylocomod 1 drop os every hour; vigamox 1 drop os every 6 hours until return.Return to emergency room (b)(6) 2019.On (b)(6) 2019 a call was placed to the pt and additional information was provided.Pt has not been back to the ecp for a follow-up visit.Pt reported a follow-up visit today, (b)(6) 2019.Pt states the os feels ok now.On (b)(6) 2019 an email was received from the pt with additional information and an attachment.¿as requested, follows the final prescription passed today by the physician and final report with future release for use of contact lens.The ecp advised the pt that the os is healing well and ¿feel the sight coming back naturally to 100%.¿ pt to continue to use both eye drops as prescribed.Ecp note dated (b)(6) 2019: ¿patient in treatment for os keratitis.Showing improvement of signs and symptoms.May return to contact lens wear in 7 days having total healing.¿ prescription dated (b)(6) 2018 for hyabak, hylogel, or hylocomod 1 drop every hour; vigamox 1 drop os qid.On (b)(6) 2019 a call was placed to the pt and additional information was provided.Ecp recommends the pt wear daily disposable contact lenses.Pt reported vigamox was prescribed qid daily until the blurry vision is back to 100 %, then discontinue.Ecp anticipated the use of 3-4 days maximum.Ecp advised pt the eyes are very dry and recommended ¿continuous¿ use of lubricating drops.Pt reported vision is improving daily and is only a little blurry currently.No return visit to the ecp is scheduled.Multiple attempts were made to the pts treating ecp for additional medical information, but nothing additional was received.The suspect os contact lens was requested for return for evaluation, but it has not yet been received.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 l003jzs was produced under normal conditions.If any further relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

A lens case was received containing 2 open lenses.The parameters of the two open lenses were measured and a visual inspection was performed.No visual attributes were observed on the first lens.Edge tears and excess polymer were observed on the second lens.The lenses meet company standards for base curve, center thickness, and diameter.This product was returned opened and it is not known what external influences may have contributed to the condition of the received lenses.If any further relevant information is received, a supplemental report will be filed.Section h ¿ 6: code 10 ¿ testing of actual/suspected device.

• 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
• MDR Report Key: 8773706
• MDR Text Key: 150823647
• Report Number: 9617710-2019-00024
• 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,other
• Type of Report: Initial,Followup
• Report Date: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/01/2023
• Device Catalogue Number: PH
• Device Lot Number: L003JZS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2019
• Date Manufacturer Received: 08/28/2019
• Patient Sequence Number: 1
• Treatment: OPTI-FREE.
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 36 YR