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 Conjunctivitis (1784); Corneal Scar (1793); Foreign Body Sensation in Eye (1869); Keratitis (1944); Local Reaction (2035); Red Eye(s) (2038); Corneal Infiltrates (2231); Eye Pain (4467)

Event Date 07/29/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, a distributor in (b)(6) advised that a patient (pt) was diagnosed on (b)(6) 2022 with ¿triple conjunctivitis, medical intervention was required¿ while wearing an acuvue® oasys® for astigmatism brand contact lens (cl).It is unknown which was the affected eye.On (b)(6) 2022, the pt provided additional medical information.The pt reported after inserting a lens in the left eye (os), the pt experienced discomfort and stinging.The suspect os cl was immediately removed and a ¿dent in the lens was visible.¿ the pt reported ¿triple keratitis¿ was diagnosed by an eye care provider (ecp) and was prescribed moxiflox every hour; tropic 0.5% bid; neomecine at night.The pt was advised to return to the ecp the following day.-treatment at the 2nd visit was xiflodrop (moxifloxacin) every hour (from sunday every 2 hours); tropicadiul tid; neomecine at night.-treatment at the 3rd visit: moxiflox 5 times a day; neomecine at night (until 24aug2022); cornergel tid.Treatment at 4th visit: softacort bid and cornergel bid.Treatment at 5th visit: cornergel bid.Pt reported ¿due to scarring on my left eye, i can¿t wear lenses anymore.¿ a follow-up visit in planned for (b)(6) 2022.On (b)(6) 2022, the translation of the pt¿s ecp medical visits were received.On (b)(6) 2022 visit: interview: urgent visit from 3 days os pain, red, without secretion, 28.07 ¿i think the pt had damaged cl on os, put the whole but pulled out the damaged, the pt is not sure if the remnant was not somewhere in the os.¿ ¿external os swelling of the eyelids, conjunctival injection, watery discharge, r - in a quadrant.Skr-dolny 3 nave, white infiltrates tangentially to the hem¿ - the largest at 5 o'clock, around the inflamed reaction from the stroma; kp clean; pupil narrow; iris calm¿ diagnosis: os keratitis recommendations: os/ today moxiflox every hour, 0.5% tropic.2x, neomycin for the night, ¿tomorrow necessarily control¿ (b)(6) 2022 visit: the patient comes for a check-up for os corneal inflammation.Os was less painful.Yesterday at ool - recom.Xiflodrop every hour, 0.5%; tropicamide 2x, ointment neomycin at night on os inflammation for about 5 days the pt wears 8 years daily (14-day, sometimes during the day sometimes falls asleep for an hour) exam os: conjunctives with congestion with a maximum in dtq, watery secretion present, smooth cornea, shiny, transparent, in os at the limbus of the cornea, "round gray deposits on no.4 and 5, around them graying of the tree", endothelium intact, pk ext., clear, str, depths, irises calm, pupil occ., in os in am, lenses in suture, clear.Fu os biomicroscopically in am: ¿ii in niveau, ohr., vital, excavation centr., macular area seems bpn, retina where can it lie, fr+, in the overlooked range without gross focal pathology, vessels filled.¿ -recommended for os: xiflodrop every hour today and tomorrow, from sunday every 2 hours; troplkamldum 3xd, ointment for the night on the way to ool on wednesday.In case of problems during the weekend the pt was instructed to have an acute check-up in a hospital.Pt will return on tuesday, pt agrees.On (b)(6) 2022 visit: interview: at the inspection the next day after the visit already much less ailments, today it is good exam: vcc: os 0.8f; ¿t od 15 thickness; os 519¿ external exam: os eyelid edema trace, conjunctival injection residual, without secretions, r - smaller and shallower infiltrates (cornea); ac clean; pupil medium wide; iris calm diagnosis: keratitis.Recommendations: os from today moxiflox 5x dz to 24.08; 0.5% tropic, set aside; neomycin for the night until 24.08; corneregel 3x dz, every week or according to your needs; corneregel: eye gel, 50 mg/g / 1 op.10 g each ds: 3xdz.On (b)(6) 2022 visit: interview: is good.Survey: vcc: os 1.0f; ¿tp op 17; t os 16).Bk (final refraction): os -2,75/-0,5/93.External os exam: calm, residual conjunctival injection, no secretion, r-minor fogging on the 5th; (cornea), no ingrown vessels; ac clean; pupil medium wide; iris calm diagnosis: keratitis os recommendations: os: softacort 2x: corneregel 2x, ex-e.G.Or as needed; corneregel®: eye gel, 50 mg/g / 1 op.10 g each ds: 2xdz to os; softacort®: eye drops, 3.35 mg/ml/1 op.30 minim each; ds: 2x1-2 kr to os on (b)(6) 2022 visit: interview: control, subj.Well, softacort finished 25.09 survey: ¿vod ccwl 1.0 external exam os: calm, residual conjunctival injection, without secretion, r-fine fogging on the 5th increasingly brighter, without ingrown vessels, kp clean; pupil medium wide; iris calm diagnosis: keratitis os recommendations: still spectacle correction only, for both eyes corneregel 2xdz, ko for 3 months or as needed.Corneregel®: eye gel, 50 mg/g/2 op.10 g each¿ ds: 2x dz os 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 b010w9j was produced under normal conditions.One opened lens was received in a lens case for lot number b010w9j.A magnified visual inspection was performed which revealed a surface tear and lens torn.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
• Manufacturer Contact: helene aguilar ; 7500 centurion parkway; jacksonville, FL 32256 ; 9047429918
• MDR Report Key: 15651480
• MDR Text Key: 302195736
• Report Number: 1057985-2022-00081
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P040045
• 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: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: B010W9J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/07/2022
• Initial Date FDA Received: 10/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2022
• 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
• Patient Outcome(s): Required Intervention; Other