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

Catalog Number PH

Device Problem No Apparent Adverse Event (3189)

Patient Problems Keratitis (1944); Blurred Vision (2137)

Event Date 08/27/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2017 a patient (pt) contacted our affiliate in (b)(4) to report staining and clouded vision (affected eye unknown) while wearing the acuvue oasys brand contact lens.The pt is currently wearing glasses and is reporting dry eye since the event in (b)(6) 2017.On (b)(6) 2017 a call was placed to the pt and additional medical information was provided: the event was the end of (b)(6) 2017.The pt reported clouded vision, but could not remove the suspect lens soon.The pt was referred to another ecp at the hospital on the same day and was told not to wear contact lenses.Pt was diagnosed with staining.The pt was prescribed eye drops but the details were unknown.Pt consulted a different ecp on (b)(6) 2017.The details of the (b)(6) 2017 visits were not provided.Additional medical information was requested from the pts treating ecp.On (b)(6) 2017 medical receipts were received from the pt.Dated (b)(6) 2017 for tarivid eye ointment 0.3% one, hyalin ophthalmic solution 0.1% 5 ml one bottle, cravit ophthalmic solution 1.5% one bottle, flumetholon ophthalmic suspension 0.1% 1 bottle.On (b)(6) 2017 additional medical information was received from the pts treating ecp: on (b)(6) 2017 pt presented to the ecp with complaints of sudden left eye vision decrease while wearing the suspect acuvue oasys brand contact lenses on (b)(6) 2017.Diagnosis: keratitis os; infectiveness: none; culture: negative.Focal site and size: almost entire part of the cornea; symptom: corneal edema, descemet¿s fold os va affect: corrected va: os 0.2 / unaided va: os 0.07 treatment: the pt was referred to (b)(6) 2017.Cl discontinued; instructed pt to follow-up with the hospital.On (b)(6) 2017, the pt consulted an ecp at the hospital: diagnosis: keratitis os; treatment: the pt was prescribed antibacterial eye drops, antibacterial eye ointment, and steroid eye drops (details of each prescription unknown).Cl discontinuation: unk pt to return on (b)(6) 2017.Follow-up visit on (b)(6) 2017: improvement was noted, continuation of the treatment required.Symptom: corneal disorder os treatment: the same as (b)(6) 2017 cl discontinuation: unknown pt to return to ecp for follow-up follow-up visit on (b)(6) 2017 at ecp: outcome: improving symptom: keratitis punctata superficialis os va: os 1.2p treatment: reduce the frequency of eye drops and eye ointment cl discontinued return on (b)(6) 2017 follow-up visit (b)(6) 2017: outcome: recovery; symptom: none; treatment: completed pt allowed to return cl wear (b)(6) 2017 instruction to return to the clinic if symptoms return no additional medical information was 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 l002g70 was produced under normal conditions.Two lenses were received in a lens case.Four sealed blisters were also received.The parameters of the two lenses were measured and a visual inspection was performed.The lens met company standards for base curve, center thickness, and diameter.No visual attributes were observed.The solution from the four sealed blisters were tested.The ph and conductivity were in specification.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

On 17jan2018 a call was received from the pt and additional information was provided: the patient (pt) reported wearing spectacles and does not wear contact lenses currently.The pt refused to provide any additional information.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
• Type of Device: LENSES, SOFT CONTACT, EXTENDED WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND; one technological park plassey; limerick ; EI
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 7162174
• MDR Text Key: 96340120
• Report Number: 9617710-2018-05001
• 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,health profe
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/01/2019
• Device Catalogue Number: PH
• Device Lot Number: L002G70
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2014
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention