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

Catalog Number PH

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

Patient Problems Corneal Ulcer (1796); Hypopyon (1913); Unspecified Infection (1930); Pain (1994); Discharge (2225); Corneal Infiltrates (2231)

Event Date 04/08/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2019 a patient (pt) called to report a diagnosis of a ¿serious cornea od infection¿ while wearing the acuvue oasys brand contact lenses.The pt is currently in treatment for the event.The pt reported this was the 12th day of the contact lens wear schedule.The pt didn¿t see anything visible on the suspect od lens.The thought it might have been a ¿stye¿ and didn¿t wear lenses over the weekend.On monday am, the pt reported the od was swollen with pus and could barely open the eye.The pt went to the eye care provider (ecp) ¿ ophthalmologist on monday and was prescribed 4 medications: natamycin 1 drop od qid, tobramycin 1 drop q30 minutes od alternating with vancomycin 1 drop q30 minutes od while awake, and cyclogyl one drop od bid.The pt reports frequent visits to the ophthalmologist.On 23apr2019 a call was placed to the pt and additional information was provided.Pt reported vision is beginning to return and improving and is currently 20/50.The pt reported the ecp will stop all medication next week and hopes there will be no scarring.Multiple calls were placed to the pts treating ecp for additional medical information.No additional medical information was provided.On (b)(6) 2019 the pts medical records were received from the pt.Via email.Visit date: (b)(6) 2019: chief complaint: pt is here for an emergency exam.Pt slept in the contacts last wednesday night.Pt states over the last few days, he has been experiencing redness, pain, swelling, blurry vision and light sensitivity on od only.Pt went to an urgent case on saturday and was given gentamycin drops which have not been helping much.Pt has also been using warm compresses od with no relief.Vision distance od: cc hm ph 20/ni; slit lamp exam od: conjunctiva: diffuse 3+ injection; cornea: infiltrate central ulcer; 1-2+ folds/striae; streamy cornea; t hypopyon chamber: deep and quiet; iris and pupil: wnl; lens: clear; assessment and plan: od: no contact lens wear until resolved.Start natacyn 5% qid od; start cyclogyl 1% bid od; start fortified tobramycin q1h od; start vancomycin q1h, alternate the fortified drops every ½ hour.Fu in 1 day.Visit date: (b)(6) 2019: chief complaint: pt here for day 1 fu exam corneal ulcer.Pt started all treatment drops and indicated (except natacyn) because pharmacy didn¿t have ready yesterday.Pt will pick-up today.Pt has noticed an improvement while indoors.Outdoors, pt still can¿t see out of od.Vision distance od: cc hm; slit lamp exam od: conjunctiva: diffuse 3+ injection.Cornea: infiltrate central ulcer; 1+ 2+ folds/striae; streamy cornea; t hypopyon, approximately 3.2 x 3.2 round, with epithelial loose ¿cap¿.Chamber: deep and quiet; iris and pupil: wnl; lens: clear.Assessment and plan od: essentially unchanged, no increase in hypopyon.Patient does not have pain, but feels vision has improved.Continue fortified antibiotics and start natamycin as soon as available from pharmacy.Continue cyclogyl 2/day.Fu tomorrow.Date of visit: (b)(6) 2019: chief complaint: pt here for 2-day fu corneal eye infection od.Pt states better than before but is still having light sensitivity.Pt has been compliant with drops and started natamycin.Pt feels improvement.Vision distance od: cc hm/pi; slit lamp exam od: conjunctiva: diffuse 3+ injection.Cornea: infiltrate central ulcer; 1+ folds/striae; approximately 3.2 x 3.2 round with epithelial loose ¿cap¿ with surrounding microcystic edema and stable white radial infiltrates.Chamber: resolved hypopyon iris and pupil: wnl; lens: clear.Assessment and plan od: contact lens related.Inflammation has improved slightly with resolved hypopyon.Pt does not have pain.Pt feels vision has improved.Continue fortified vanc/tobra q1h and natamycin qid od; continue cyclogyl bid od; fu in 1 day.Date of visit: (b)(6) 2019: chief complaint: pt in for fu corneal infection od.Pt states it¿s getting better that before but still has light sensitivity.Pt has been compliant with drops and started natamycin.Pt feels improvement.Pt states that there is a shade over the od but is able to see slightly.Pt denies pain or discomfort.No refraction.Vision distance od: cc 20/600; ph 20/250; slit lamp exam od: conj: diffuse 3+ injection; cornea: infiltrate central ulcer; 1+ folds/striae; approximately 3.1 x 3.1 round, with epithelial loose ¿cap¿ surrounding microcystic edema and stable white radial infiltrates chamber: resolved hypopyon; iris and pupil: wnl; lens: clear.Assessment and plan od: conjunctival injection improved and pt states vision is getting better.Infiltrate very slightly less in size.Add vitamin c 3gms/day.Continue drop regimen.Contact lens related.Inflammation has improved slightly with resolved hypopyon.Pt does not have pain.Pt feels vision has improved.Continue fortified vanc/tobra q1h and natamycin qid od.Alternate fortified antibiotics every ½ hour.Continue cyclogyl bid od.Fu tomorrow.Date of visit: (b)(6) 2019.Chief complaint: pt here for fu corneal ulcer od.Pt states vision in od is still blurry and continues to experience light sensitivity.Pt has noticed tearing at night as well.Vision distance od: cc 20/300; ph 20/ni; slit lamp exam od: conj: diffuse 3+ injection.Cornea: infiltrate central ulcer; approximately 3.1 x 3.1 round, with epithelial loose ¿cap¿ with surrounding microcystic edema and stable with radial infiltrates chamber: resolved hypopyon; iris and pupil: wnl; lens: clear.Assessment and plan od: cl-related ulcer; conjunctival injection improved and pt states vision is getting better.Infiltrate very slightly less in size.Hypopyon resolved.No pain.Continue vitamin c 3 gms/day.Continue fortified vanc/tobra q 1 h and natamycin qid od.Alternate fortified antibiotics every ½ hour.Continue cyclogyl bid od.Date of visit: (b)(6) 2019: chief complaint: pt here for 1-week fu.Pt states vision in the od is improving.Compliant with drop instructions.No pain or discomfort and redness od has subsided.No longer has tearing od.Vision distance od: cc 20/150; ph 20/80+2; slit lamp exam od: conjunctiva: diffuse 3+ injection.Cornea: infiltrate central ulcer; 1+ folds/striae; very slightly, approximately 3.1 x 3.1 round, with epithelial loose ¿cap¿ with surrounding microcystic edema and stable white radial infiltrates, honeycomb appearance.Chamber: resolved hypopyon; iris and pupil: wnl; lens: clear.Assessment and plan od: cl-related, very slightly improved.Conjunctival injection improved and pt states vision is getting better.Infiltrate very slightly less in size.Hypopyon resolved.No pain.Continue vitamin c 3 gms/day.Continue fortified vanc/tobra q1h and natamycin qid od.Can decrease amount of alternating fortified antibiotics every 1 hour.Continue cyclogyl bid od.Date of visit: (b)(6) 2019: chief complaint: pt presents for 2-day fu monitoring a corneal ulcer in the od.Pt is noticing improvement and vision is clearing up.He is using the drop schedule as directed.No pain is noted, but still has some light sensitivity.Redness is reduced.He has not been wearing contacts.Vision distance: od: cc 20/100- ph 20/50-2; distance desc, blurry od; slit lamp exam od: conjunctiva: diffuse 2+ injection; less conjunctival injection.Cornea: infiltrate central ulcer; absent folds/striae; very slightly improved, approximately 3.1 x 3.1 round, with epithelial loose ¿cap¿ with surrounding microcystic edema and stable white radial infiltrates, honeycomb appearance, stroma less cellular chamber: resolved hypopyon; iris and pupil: wnl; lens: clear; assessment and plan: od: cl-related ulcer, very slightly improved.Conjunctival injection improved and pt states vision is getting better.Infiltrate very slightly less in size.Hypopyon resolved.Pt does not have pain; continue vitamin c 3 gms daily; continue fortified vanc/tobra q 2h and natamycin qid od.Can decrease amount of alternating fortified antibiotics every hour.Continue cyclogyl qhs.Can use preservative free tears.Slowly improving.Fu: saturday.The suspect od contact lens was discarded.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 b00lwtx was produced under normal conditions.If any further relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

On (b)(6) 2019 a call was placed to the patient (pt) who reported the od is not completely healed.The pt reported an upcoming appointment with the eye care provider next week and will send any additional medical reports when available.No additional medical information was provided.If any further relevant information is received, a supplemental report will be filed.

• Brand Name: ACUVUE OASYS
• 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: 8592832
• MDR Text Key: 144662521
• Report Number: 1057985-2019-00042
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): Y
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/01/2021
• Device Catalogue Number: PH
• Device Lot Number: B00LWTX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/15/2019
• Initial Date FDA Received: 05/08/2019
• Supplement Dates Manufacturer Received: 05/24/2019
• Supplement Dates FDA Received: 06/18/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 27 YR