MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ US ACUVUE 2; LENSES, SOFT CONTACT, EXTENDED WEAR

Catalog Number AV2

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

Patient Problems Inflammation (1932); Keratitis (1944); Pain (1994); Red Eye(s) (2038); Swelling (2091); Blurred Vision (2137); Discharge (2225); Excessive Tear Production (2235)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2020 an eye care provider (ecp) in (b)(6) sent an email advising a patient (pt) was diagnosed with keratitis (affected eye not provided) while wearing the acuvue® 2® brand contact lenses.On (b)(6) 2020 a call was placed to the pt and additional medical information was provided: the pt experienced blurry vision, especially in the left eye (os) upon removal of the suspect lenses.The pt will go to the ecp again to check the status of the eyes as they have not yet recovered.The date of event is reported as (b)(6) 2020.On (b)(6) 2020 the medical report was received with the additional information: date: (b)(6) 2020 ¿ ophthalmology center pt reported os blurry vision, tearing and secretions for a week; od blurry vision for 1 day; pt denies history of systemic illness.Pt reports contact lens wear in the past few days.¿vod:0.16sc 0.63cc; vos:0.16sc 0.63cc¿.Exam: ou conjunctiva clear; cornea clear od; scattered spk (superficial punctate keratitis) with infiltration os; pupil 2.5 mm responsive to light ou; fundus not detected, (un-dilated); drawing depicts: fl+ os.Diagnosis: keratitis os; ametropia ou.The pt was prescribed: levofloxacin tablets ou qid; tobramycin eye drops ou qid; gatifloxacin eye gel ou q hs; ganciclovir sol ou qid; ganciclovir gel ou q hs; f/u in 3 days in general clinic, pt advised to return to clinic if any complaints; stop cls wear.Based on the diagnosis provided, the event was reviewed and determined to be non-reportable adverse event to the health authorities at this time.(b)(6) 2020 f/u: unreadable information provided.On (b)(6) 2020 a call was received from the pt who reports the os continues with blurry vision even with wearing glasses and will return to the ecp.No additional medical information was provided.On (b)(6) 2020, the pt reported a visit with the ecp over the weekend and will send the medical report.On (b)(6) 2020, the pt reported a ¿pin prick sensation¿ and will go to the ecp after work.No additional medical information was provided.On (b)(6) 2020 the pt reported that the ecp reported a diagnosis from keratitis to scleritis os.The pt reported the ecp advised ¿it might affect the pts immunity.¿ the pt also reports ¿several tests on (b)(6) 2020.¿ the pt reported that 3 reports show everything is normal, but currently there are 3 more reports pending.The pt advised the ecp has not prescribed any further medication since test results are pending.The pt is currently using the previously prescribed eye drops.The pt refused to provide any additional information at that time.Based on this additional information received on (b)(6) 2020, the event was re-evaluated and determined to be a possible reportable os event to the local health authorities.The od event was determined as not reportable at this time.On (b)(6) 2020 the pts medical report was provided: date: (b)(6) 2020.Vos: 0.63.The record indicates the pt complained of os redness and swelling for greater than 3 months; the pt was diagnosed with scleritis os (conjunctiva redness nasal upper os, scleral vascular hyperemia and vessel engorgement).The pt was prescribed tobramycin and dexamethasone eye drops os qid, diclofenac sodium eye drops os qid; and tobramycin and dexamethasone eye ointment os q hs; fu next week.Date: (b)(6) 2020 ¿ ophthalmology department visit.Chief complaint: redness and swelling of left eye more than 3 months; pt is followed by eye hospital.Re: conjunctival redness, nasal upper os; scleral vascular hyperemia, vessel engorgement, corneal epithelium intact, fl(-); ¿l14 14 14¿.Diagnosis: scleritis of left eye, ??? xxxx not readable.Prescriptions: tobramycin and dexamethasone eye drops os drops qid; diclofenac sodium eye drops os drops qid; tobramycin and dexamethasone eye ointment os drops q hs.On (b)(6) 2020 medial report provided: date: (b)(6) 2020; diagnosis: keratitis.Prescriptions: sulfate gentamicin and fluorometholone eye drops 1 eyedrop qid os; sodium hyaluronate eye drops 2 eyedrops qid os; recombinant human interferon a2b eye drops 1 eyedrop qid os.No additional medical information was provided.On (b)(6) 2020 the pt reported that the eye condition is recovering after switching to a different hospital.Pt advised all the test results have come back normal.The pt advised the condition is only in the os surface.The ecp recommended ¿amcinonide¿ with later re-testing.Pt refused the ¿amcinonide¿ and only applies ¿eye drops.¿ the pt will provide results including ¿type-b ultrasound¿ and blood tests.The pt reports a possible need multiple for ecp visits.On (b)(6) 2020 an additional medical report was provided: date: (b)(6) 2020 ¿ ophthalmology department visit.Medication: tobramycin and dexamethasone eye ointment bid; artificial tears 5ml ou qid chief complaint: follow up, information not readable.Re: unreadable redness, edema; ¿dva: os 0.6; l:14 14 15 14.4¿.Prescribed: unreadable os; b-scan; unreadable.On (b)(6) 2020 a translation of the pts medical test results were received.Date of printing: (b)(6) 2020.¿rheumatism¿ serum testing: within normal limits.Date of printing: (b)(6) 2020.Serum testing hep b antigen and antibody testing ¿ negative.Date of printing: (b)(6) 2020.Serum thyroid testing ¿ within normal limits.Date of printing: (b)(6) 2020.¿vasculitis¿ serum antibody and antigen testing: negative.Date of printing: (b)(6) 2020.¿autoantibody¿ series serum antibody testing ¿ negative.Date of printing: (b)(6) 2020.Ophthalmic ultrasound examination report: no obvious abnormality in the left eye.On (b)(6) 2020 a call was placed to the pt and additional information was provided.The pt reported the ¿eye conditions are gone and recovered, but only has a bit of edema.¿ pt is still applying the same eye drops prescribed from ¿time to time¿ that were prescribed by the first doctor.No additional medical information 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 b00r8f2 was produced under normal conditions.The suspect os contact lens was discarded.No additional investigation can be conducted.If any further relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

On 08apr2020 the patient (pt) reported an eye care provider (ecp) visit is scheduled for (b)(6) 2020.The medical report was requested from the pt.The pt also sent an email with a medical report dated 07apr2020.Date of visit: (b)(6) 2020.Distant vision: os:0.6; ¿nct: l [19 16], 17.5mmhg.¿ chief complaint: left eye red for two months.History of present illness: point tenderness.Pe: mixed hyperemia (++); point tenderness.Imp: scleritis os.Medications: 2% lidocaine 0.1ml; dexamethasone2.5mg; tobradex ointment f/u.On 09apr2020 the pt sent an email advising that a medical report was requested from the hospital, but the pt was advised the pt goes for a ¿formal thorough examination in the hospital, a medical report can not be issued.¿ on 10apr2020 a medical report was received from the pt.Date of visit: (b)(6) 2020.Distant vision: os: not recorded; ¿nct: ¿l [20 21 20] 20.3mmhg¿.Pe: mixed hyperemia (++).Imp: scleritis os.Medications: 2% lidocaine 0.1ml; dexamethasone2.5mg; prednisone 30mg qd; omeprazole and unreadable wording xxx.No additional medical information has been received.If any further relevant information is received, a supplemental report will be filed.

• Brand Name: ACUVUE 2
• Type of Device: LENSES, SOFT CONTACT, EXTENDED WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. ¿ US; 7500 centurion parkway; jacksonville FL
• MDR Report Key: 9921075
• MDR Text Key: 196465184
• Report Number: 1057985-2020-00028
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): Y
• PMA/PMN Number: N18033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/01/2023
• Device Catalogue Number: AV2
• Device Lot Number: B00R8F2
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention