MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE - IRELAND ACUVUE® 2®; LENSES, SOFT CONTACT, EXTENDED WEAR

Catalog Number AV2

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

Patient Problems Chemosis (1775); Corneal Edema (1791); Corneal Scar (1793); Dry Eye(s) (1814); Eye Injury (1845); Local Reaction (2035); Red Eye(s) (2038); Blurred Vision (2137); Excessive Tear Production (2235); Eye Pain (4467); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/04/2023

Event Type  Injury  

Event Description

On 11 sep 2023, an online distributor in china reported a patient (pt) was diagnosed with ¿corneal injury¿ while wearing the acuvue® 2® brand contact lenses (cls).No additional medical information was provided.On 11sep2023, the pt provided additional medical information.On (b)(4) 2023, the pt experienced blurry vision in both eyes (ou) ¿after a period of wearing¿ cls with discomfort and blurry vision that continued after the cls were removed.The pt sought medical attention and was diagnosed with ¿bacterial infection, eye inflammation and corneal injury.¿ the pt was prescribed flumetholon eye drops 2-4 times a day and sodium hyaluronate eye drops, no more than 6 times a day.The pt reported both eyes "were fine now." multiple attempts were made to obtain additional medical information from the pt on 12sep2023, 14sep2023, and 15sep2023 with no success.On 19sep2023, the pt provided reports for 07jul2023, 18jul2023 and 09sep2023 medical visits.On 20sep2023, translations of the pt¿s medical reports were received.Visit date: (b)(6) 2023.Diagnosis: corneal injury ou.Admission status: eye pain in ou after wearing cls for 1 hour.Examination: normal eyelids, normal lacrimal apparatus, conjunctival congestion and edema, corneal epithelial flaky exfoliation, kp(-), normal sclera, normal anterior chamber depth, clear aqueous humor, round pupils, normal light reflex, pupil diameter of 3mm, transparent crystal, transparent vitreous body, normal fundus , normal retinal color, center of macula (-).Iop: od:15mmhg, os:16mmhg.Diagnosis and treatment: after admission, routine examinations such as blood routine and biochemical tests should be improved, and dexamethasone injection 5mg intravenous drip anti-inflammatory.Local administration of ofloxacin eye drops for anti-infection in both eyes, fluorometholone eye drops for anti-inflammation in both eyes, recombinant human epidermal growth factor eye drops for promoting corneal epithelial repair.Discharge status: pt¿s eye pain was significantly improved compared with before, and there were no other systemic symptoms of discomfort, mild congestion in both eyes conjunctival, slight defect of corneal epithelium, kp (-), normal sclera, deep anterior chamber, clear aqueous humor, round pupil, sensitive light reflex, diameter 3mm, transparent crystal, normal fundus, and iop.Discharged medical advice and precautions: take medicine on time and follow up (fu) with an ophthalmologist for one week after discharge.Date of visit: (b)(6) 2023.Complaint: fu for photophobia after wearing cls in ou.Medical history: fluorometholone eye drops and sodium hyaluronate eye drops were used.Eye examination: tears in both eyes shallow, punctate corneal epithelial keratopthy, normal anterior chamber, round pupils, and normal lenses.Diagnosis: corneal epithelial injury, dry eye syndrome.Prescribed medication and fu: fluorometholone eye drops, four times a day (qid); ofloxacin eye drops, once a night; cyclosporine eye drops qid; recombinant human epidermal growth factor eye drops; wear bandage lens if necessary; further evaluation by corneal and ocular surface experts is recommended.Date of visit: (b)(6) 2023 complaint: pain in ou with blurred vision, 2-month fu examination.Medical history: fu for pain in ou and blurred vision two months ago, symptom relief after treatment.Preliminary diagnosis: cornea epiththeal keratopthy.Suggestion for fu consultation: if you feel unwell, have an ophthalmic outpatient review.Attention: corneal epithelial injury has healed, do not rub the eyes.On 20sep2023, the pt provided additional information.No "bacterial infection" was diagnosed.The pt will email the remaining medical reports.On 20sep2023, clarification of the medical report dated 07jul2023 was received.The medical report indicates the pt was admitted to the hospital on (b)(6) 2023 and discharged on (b)(6) 2023.This "corneal injury" was determined to be a serious adverse event with the additional information provided on 20sep2023 that the pt was admitted to the hospital on (b)(6) 2023 and discharged on (b)(6) 2023.On 22sep2023, the pt reported the hospital admission was due to eyes being difficult to open, feeling painful and blurry vision after wearing cls for less than one hour.The pt reported ¿the eyes got better from the hospital treatment.¿ on 22sep2023, the medical reports for visits dated (b)(6) 2023 were received.On 24sep2023, translations of the pt¿s medical reports were received for visits dated (b)(6) 2023.Date of visit: (b)(6) 2023: complaint: fu for photophobia after wearing cls in both eyes medical history: fluorometholone eye drops and sodium hyaluronate eye drops were used.Eye examination: tears in both eyes shallow, punctate corneal epithelial keratopthy, normal anterior chamber, round pupils, and normal lenses.Diagnosis: bilateral corneal epithelial injury, high myopia.Prescribed: recombinant bovine basic fibroblast growth factor eye-gel qid; recombinant human epidermal growth factor eye drops qid; tobramycin eye drops qid; wear bandage lens if necessary; further evaluation by corneal and ocular surface experts is recommended.Date of visit: (b)(6) 2023: complaint: blurred vision in both eyes for 12 days after wearing cls.Current medical history: after wearing corneal cls in both eyes, vision blurred for 12 days, foreign body sensation.Patient treated with recombinant bovine basic fibroblast growth factor eye-gel, recombinant human epidermal growth factor eye drops, fluorometholone eye drops, sodium hyaluronate eye drops, ofloxacin eye drops , tobramycin eye drops.Eye examination: dotted opacity of corneal epithelium in both eyes, low tear flow, mild conjunctival congestion.Diagnosis: dry eye syndrome, corneal epithelial exfoliation.Processing: corneal photos, corneal staining, dry eye analysis.Prescribed: diquafosol sodium eye drops every 4 hours for 7 days; sodium hyaluronate eye drops qid for 14 days.Date of visit: (b)(6) 2023 complaint: fu for photophobia after wearing cls in both eyes medical history: fluorometholone eye drops and sodium hyaluronate eye drops were used.Eye examination: tears in both eyes shallow, punctate corneal epithelial keratopthy, normal anterior chamber, round pupils, and normal lenses.Diagnosis: bilateral corneal epithelial injury, high myopia.Prescribed: recombinant human epidermal growth factor eye drops qid; wear bandage lens if necessary; further evaluation by corneal and ocular surface experts is recommended.On 09oct2023, the translated medical reports were received dated (b)(6) 2023 and 11jul2023.Date of visit: (b)(6) 2023 at ophthalmic emergency department: the pt complained of photophobia and tearing in both eyes after 1 hour of wearing contact lenses.Exam revealed conjunctival hyperemia, corneal epithelium exfoliation, corneal opacity and edema, corneal injury, clear anterior and normal chamber depth.The pt was diagnosed with conjunctival corneal injury and was instructed to use recombinant human epidermal growth factor eye drops qid and fluorometholone eye drops bid.The pt was instructed to follow-up (fu) for any discomfort, pay attention to eye hygiene, avoid rubbing eyes and prevent corneal infection.Date of visit: (b)(6) 2023 ¿ ophthalmology department.Chief complaint of blurred vision in both eyes for 1 month with no eye pain.Fundus exam showed no obvious abnormality; intraocular pressure was normal.Pt corrected vision was 1.0 in both eyes (snellen: 20/20).Pt was diagnosed with corneal epithelial injury and advised to use sodium hyaluronate 0.1% eye drops tid.Pt was instructed to fu for ophthalmic re-examination in 3 months, wear glasses correctly and wear contact lenses under the guidance of an ophthalmologist.The pt is unwilling to provide inpatient medical reports.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 l0056dg was produced under normal conditions.This report is for the pt's os event.A separate report will be submitted for the pt's od event.The pt refused to return the os suspect cl.No additional evaluation can be performed.If any further relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

H3 other text : suspect product not available.

• Brand Name: ACUVUE® 2®
• 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: 17927361
• MDR Text Key: 325573619
• Report Number: 1057985-2023-00074
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: N18033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: AV2
• Device Lot Number: L0056DG
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2021
• 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
• Patient Outcome(s): Hospitalization; Required Intervention; Other; Disability