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

Catalog Number CYP

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

Patient Problems Corneal Scar (1793); Corneal Ulcer (1796); Dry Eye(s) (1814); Itching Sensation (1943); Keratitis (1944); Neovascularization (1978); Local Reaction (2035); Visual Disturbances (2140); Eye Pain (4467)

Event Date 02/01/2021

Event Type  Injury  

Manufacturer Narrative

Suspect product discarded.

Event Description

On 18mar2021 an email titled, eye damage was received from a patient (pt) in (b)(6), reporting a diagnosis of contact lens related keratitis and an ulcerated cornea (affected eye not provided) while wearing the acuvue¿ oasys¿ for astigmatism brand contact lenses (cls).The pt reported experiencing immediate pain upon insertion of the lens in the eye.The pt took a 2nd cls from the pack and advised the lens was split.The pt has received treatment at the eye clinic at a hospital.No additional information was provided.On 18mar2021 the pt called to provide additional information.The pt notified the cls supplier of the issues with the lenses in (b)(6) 2021.The issue occurred with the od as soon as the pt placed the suspect cls on the eye.The suspect cls was removed due to the discomfort and the pt discontinued cls wear for 2 days.The pt tried another cls, experienced discomfort, then removed the suspect cls and noted a little chip or a tear on the lens.The suspect lenses were discarded, and the remaining lenses were returned to the cls supplier.The pt has not returned to cls wear and is currently wearing glasses.On 29mar2021 the pt provided additional information.The pt reported the diagnosis from the doctor was contact lens related sterile keratitis.The pt was prescribed prednisolone tid and levofloxacin hourly.The 1st hospital appointment was (b)(6) 2021 with a follow-up appointments on (b)(6) 2021.The pt was discharged on (b)(6) 2021 and the prescribed medications were discontinued on (b)(6) 2021.The pt reported the od vision had improved but advised there is still scarring, but no inflammation from the ulcer.The pt has the medical reports and is willing to provide them.Multiple attempts were made to the pt to request the medical reports, but nothing additional has 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 b00vqm2 was produced under normal conditions.The suspect od cls were discarded, no additional evaluation can be conducted.If any further relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

On (b)(6) 2021, medical records were received from the patient (pt).Date of visit: (b)(6) 2021.Diagnosis: od contact lens related sterile keratitis (mild suspicion) today.Prescription: levofloxacin 0.5% eye drops pres-free, 1 drop od, every hour for 2 days, two times a day for 7 days, every two hours for 2 days, four times a day for 7 days.Visual acuity: od 6/9 best corrected (6/6 pinhole).Iop: 14 mmhg od.Management/plan: referred by general practitioner for possible corneal ulcer.Pt wears disposable cl and changes them every 2 weeks.Od uncomfortable and itchy for 1 week, has not been wearing a cl since the initial symptoms.¿on examination ? contact lens related keratitis in the right eye.¿ prescribed g oftaquix every hour for 2 days, then every 2 hours until return.Pt to return in 3 days.Follow-up appointment: (b)(6) 2021.Date of visit: (b)(6) 2021.Diagnosis: od contact lens related sterile keratitis (mild suspicion) ((b)(6) 2021).Prescription: prednisolone 0.5% eye drops, 1 drop od, three times a day for 4 weeks.Current eye medication: levofloxacin 0.5% eye drops pres-free, 1 drop od, two times a day until (b)(6) 2021, every two hours until (b)(6) 2021, four times a day until (b)(6) 2021.Visual acuity: od 6/9 best corrected (6/6 pinhole).Iop: 13 mmhg od.Management/plan: right eye corneal ulcer not improving.G predsol tds added for the inflammation.Pt to return in 5 days.Follow-up appointment: (b)(6) 2021.Date of visit: (b)(6) 2021.Diagnosis: od contact lens related sterile keratitis (mild suspicion) ((b)(6) 2021).Current eye medication: prednisolone 0.5% eye drops, 1 drop od, three times a day until 0(b)(6) 2021; levofloxacin 0.5% eye drops pres-free, 1 drop od, four times a day until (b)(6)2021.Visual acuity: od 6/6 best corrected.Iop: 14 mmhg od.Management/plan: reviewed today following recent diagnosis of circumferential ulcer in the right eye.Pt is using drops as prescribed and reports both vision and symptoms have improved.On the examination circumferential ulcer improving.Iop satisfactory.Advised to continue g predsol tds & g levofloxacin tds with no contact lens wear.Pt to return in 2 weeks.Date of visit: (b)(6) 2021.Diagnosis: od contact lens related sterile keratitis (mild suspicion) ((b)(6) 2021).Current eye medication: prednisolone 0.5% eye drops, 1 drop od, three times a day until (b)(6) 2021; levofloxacin 0.5% eye drops pres-free, 1 drop od, four times a day until (b)(6) 2021.Visual acuity: od 6/5 best corrected.Iop: 13 mmhg od.Management/plan: reviewed today following recent contact lens related sterile keratitis.Using eye drops as prescribed and symptoms have improved.On examination no staining with fluorescein, iop satisfactory and no inflammation in the anterior chamber.Advised to continue drops as prescribed for the following 3 days.Pt has been discharged from further follow-up.Date of visit: (b)(6) 2021.Diagnosis: od contact lens related sterile keratitis (mild suspicion) ((b)(6) 2021).Prescription: chloramphenicol 1% eye ointment, 1 cm od, four times a day for 2 weeks; prednisolone 0.5% eye drops unit dose pre-free, 1 drop od, three times a day for 2 weeks; sodium hyaluronate 0.2% eye drops pres-free, 1 drop od, four times a day for 2 weeks.Visual acuity: od 6/6 best corrected.Iop: 16 mmhg od.Management/plan: clinically inferior marginal keratitis.No fluorescein take-up.Ac quiet.Chloramphenicol ointment qds along with 0.5% prednisolone preservative free drops 3 times daily.Return after 72 hours and contact sooner for any concerns.Follow-up appointment: (b)(6) 2021.Date of visit: (b)(6) 2021.Diagnosis: od marginal keratitis ¿ today; od anterior lid margin disease ¿ today; od contact lens related sterile keratitis (mild suspicion) (b)(6) 2021).Prescription: maxitrol eye ointment, 1 cm od, two times a day for 4 weeks; doxycycline 100 mg capsules, 1 tablet orally, once a day for 3 weeks.Current eye medication: sodium hyaluronate 0.2% eye drops pres-free, 1 drop od, four times a day until (b)(6) 2021.Drugs discontinued: prednisolone 0.5% preservative-free unit dose eye drops (minims), and chloramphenicol 1% eye ointment.Visual acuity: od 6/6 best corrected.Iop: 17 mmhg od.Management/plan: much improved symptomatically.Marked right lower lid telangiectasia.Corneal ulceration healed with inferior mild corneal scarring.Mild inferior corneal vascularisation.For regular lid hygiene and warm compresses.Oc maxitrol 2x ¿re 4/52¿ and start oral doxycycline.See corneal clinic (with no contact lens wear in the interim).Follow-up appointment: approximately 4 weeks.No additional information was received.If any further relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

On (b)(6) 2021, the patient reported currently being unable to wear contact lenses.No additional information was received.No additional information is expected.If any further relevant information is received, a supplemental report will be filed.

• 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 32256
• MDR Report Key: 11642692
• MDR Text Key: 244730720
• Report Number: 1057985-2021-00124
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• 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: B00VQM2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention