MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE - IRELAND 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 Bacterial Infection (1735); Foreign Body Sensation in Eye (1869); Iritis (1940); Keratitis (1944); Red Eye(s) (2038); Loss of Vision (2139); Eye Infections (4466); Eye Pain (4467)

Event Date 07/22/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, a johnson and johnson sales representative advised that a patient (pt) in turkey reported stinging and burning (date not provided) in the left eye (os) after wearing an acuvue® oasys® for astigmatism brand contact lens (cl) for ¿nearly a week.¿ the pt visited a hospital (date not provided) and was prescribed zaditen 8 times a day and artificial tears 2 times a day.The pt was referred to a second hospital (date not provided) and was advised by the doctor ¿that it could be caused by the use of lenses, and they said that it was keratitis.¿ the pt was given ¿a special mixture of antibiotics made in the hospital,¿ 1 drop per hour.The pt stated, ¿the infection in the eye was noticeable from the outside¿ and the pt ¿cannot see¿ with the os.The pt also provided a picture of a red eye.On (b)(6) 2022, additional information was provided.The pt ¿wore the lens on (b)(6) 2022 and the ¿complaint started on (b)(6) 2022.¿ the pt reports that the os treatment is still ongoing.The pt provided medication names as klorheksidin, 1 drop every 4 hours; amikasin, 1 drop ¿every hours¿ and vigamox, 1 drop every 4 hours.The pt reports the os vision is the same, the pt ¿does not see anything.¿ the doctor mentioned that the pt has ¿keratitis¿ and has not taken ¿medical report from the doctor yet.¿ the pt reported when the hospital provides the medical report, the pt will share it.Multiple attempts to obtain additional medical information have been made.No additional medical information has been received.A lot history review was performed and revealed the following: the batch records did not show any abnormalities in monomer and solution testing.All parameters tested were within specification.All sterilization requirements were successfully completed.Lot number l0057pq was produced under normal conditions.One lens case containing one lens was received for lot l0057pq.Five sealed blister packages were also received for lot l0057pq.A magnified visual inspection was performed which revealed no abnormalities with the opened lens.The solution of the five sealed blister packages was also tested; the ph and conductivity were within specification.If any further relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

On 10oct2022, a translation of additional medical information was provided by the turkey affiliate.Summary of the information provided: photo # 1 (no date provided): ¿ceftazidime hourly, eyestil every 2 hours were started netira, which was started to the patient at the external center was discontinued the patient was asked to come to control visit the next morning.Photo #2 - (no date provided): ¿iop: os: 8 mmhg slit lamp findings: left eye: conjunctival hyperemia, 4 positive cells in the anterior chamber, punctate epithelial erosion, dye (+) keratitis focus, melting progressed to stroma fundus findings: os normal the patient was consultated to specialist md with examination notes of infectious diseases clinic, gynecology clinic and pediatrics clinics.Antibiotherapy of the patient was designed in accordance with the examination notes of these clinics and clinical evaluation.Under local anesthesia, with a sterile needle, corneal sampling was performed and the material was sent to microbiological examination.¿ photo # 3: ¿24/07 visual acuity: os: 5-6/10 (-3.25-2.00@175 (illegible) slit lamp: os: conjunctival hyperemia, dye positive keratitis focus, melting progressed to stroma iop: os: 15¿ photo # 4: (b)(6) 2022.Redness in eyes for the last 2 days.The patient doesn¿t sleep with cl.The sampling examination results are not obtained yet.Ceftazidime every hour (night time included), eyestil every 2 hours visual acuity: os: 0.16 slit lamp: os: conjunctival hyperemia, demonstration of left cornea: leukocyte ring, keratitis focus, melting, fine keratic precipitates on endothelial layer¿ photo #5: the patient was consulted: acanthamoeba due to cl? the patient was referred to university for confocal microscopy.Chlorhexidine and brolene will be initiated according to the result.The patient was reinformed that her disease is severe and the patient might lose the eye.(b)(6) 2022.Confocal microscopy has been performed.The opinion was received as no fungal cells were observed, acanthamoeba trophozoite-like view was observed, causative agent might be bacterial or trophozoite, and acanthamoeba treatment initiation was recommended.¿ slit lamp: demonstration of left cornea: dye (-)¿ photo # 7: ¿the patient was consulted.Chlorhexidine drop 6x1 was added.Microbiological results were not obtained.(b)(6) 2022.Direct visualization: pseudomonas amikacin sensitive; ceftazidime resistant zidime was stopped.¿ photo # 8: dear gynecology clinic, 13-day old postpartum patient, breast-feeding.The patient has severe keratitis (pseudomonas) on the left eye.The pt was using ceftazidime drops 8x1 since saturday.We want to change the treatment to amikacin and moxifloxacin due to the resistance to ceftazidime, which was shown by antibiogram result.We ask your consent if this treatment has any contraindications with breast-feeding.¿ photo # 9: (no date provided) ¿(same photo with 7th photo, just the bottom was cut on 7th) zidime was stopped.Amikacin and vigamox were started every 2 hours alternately, which will be used 24 hours.Approval was received from gynecology clinic.¿ photo # 10: (b)(6) 2022.Pain, redness and stinging at the left eye that lasts for the last 3 days.The patient first admitted to an external center, and there, she was told that her eye could be perforated.Netira 8x1, eyestil 2x1 was prescribed there.The patient is a cl user for 7 years, and she removed the lens due to pain.Visual acuity: os: 7/10 (-3.25-2.00@145) no additional information has been received.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 - IRELAND; 1 technological park plassey; limerick LK130 01; EI LK13001
• Manufacturer Contact: helene aguilar ; 7500 centurion parkway; jacksonville, FL 32256 ; 9047429918
• MDR Report Key: 15245611
• MDR Text Key: 298112053
• Report Number: 1057985-2022-00060
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• 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: L0057PQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/02/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: HYFRESH SOLUTION
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Female