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

Catalog Number PH

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Corneal Abrasion (1789); Iritis (1940); Irritation (1941); Itching Sensation (1943); Keratitis (1944); Pain (1994); Red Eye(s) (2038); Swelling (2091); Discomfort (2330)

Event Date 07/03/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2019, an email was received from a patient (pt) in (b)(6) who initially reported a diagnosis of an ¿ulcer¿ while wearing acuvue® oasys® brand contact lenses (cl).On (b)(6) 2019, a call was placed to the pt to obtain additional information.The pt inserted a new cl in the left eye (os) on (b)(6) 2019 and immediately felt discomfort.Within an hour, the os was itchy, red, swollen, felt scratchy, and the pt ¿couldn¿t see.¿ the pt was unable to remove the cl and complained of pain.On (b)(6) 2019 the pt presented to the dispensing the eye care provider (ecp).Pt stated the ecp removed the cl and found ¿2 small particles embedded in it.¿ the pt was allegedly diagnosed with an ¿ulceration¿ and was referred to an ophthalmologist.The pt was prescribed chlorsig eye drops to apply 4 times a day.The pt reported seeing the ophthalmologist on (b)(6) 2019 and was prescribed maxidex eye drops 4 times per day.On 1(b)(6) 2019 the treating ophthalmologist was contacted and that the pt was diagnosed with a ¿vertical linear abrasion.¿ no further information was provided.Based on the reported diagnosis, the event was determined to be non-reportable to the applicable health authorities.On (b)(6) 2019 the pt was contacted and reported the os was ¿completely back to normal.¿ the pt tried to wear a cl and the os ¿is ok.¿ on (b)(6) 2019, a summary of the pt¿s medical report (dated (b)(6) 2019) was received from the treating ophthalmologist.The summary indicated the following: (b)(6) : the pt inserted the cls and the os felt a little irritated and 2 hours later the os became sore and swollen.(on b)(6) 2019: the pt presented to the treating ophthalmologist.Va ¿6/9-2¿ with glasses.A central linear abrasion with mild underlying striate keratopathy and ¿a half a plus of cells in the anterior chamber¿ was noted.Eye pressure was normal.Diagnosis: abrasion and secondary keratitis/reactive iritis to the cl.A standard treatment of chlorsig eye drops was prescribed 4 times a day.On (b)(6) 2019 f/u: pt¿s vision had deteriorated to ¿6/12¿.Cornea showing some oedema with some plaque and keratitis precipitates on the endothelium.Prescribed maxidex eye drops 4 times a day.On (b)(6) 2019 f/u: pt¿s vision had improved to 6/6.Os was comfortable and the cornea was clear.The pt was advised not to wear cls for a month.No further follow-up was required.On (b)(6) 2019 f/u: pt was advised to resume cl wear.Based on the information received on 04sep2019, the event was re-evaluated and determined to be reportable due to the reported diagnosis of reactive iritis os.The diagnosis of reactive iritis os was not reported by the treating ophthalmologist when contacted on (b)(6) 2019.The medical information received from the treating ophthalmologist confirms that the pt was not diagnosed with a corneal ulcer as the pt originally reported.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 b00rlpj was produced under normal conditions.A lens case was received containing 1 open lens.The parameters of the open lens were measured and a visual inspection was performed.Excess polymer was observed on the lens.The lens met company standards for base curve, center thickness, and diameter.This product was returned opened and it is not know what external influences may have contributed to the condition of the received lens.If any further relevant information is received, a supplemental report will be filed.

• 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
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 9125566
• MDR Text Key: 165443743
• Report Number: 1057985-2019-00088
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): Y
• Reporter Country Code: AS
• 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: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2019
• 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: B00RLPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2019
• Date Manufacturer Received: 09/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2018
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention