MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ US 1-DAY ACUVUE MOIST; LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number 1DM

Device Problem No Apparent Adverse Event (3189)

Patient Problems Corneal Abrasion (1789); Corneal Ulcer (1796); Foreign Body Sensation in Eye (1869); Irritation (1941); Keratitis (1944); Pain (1994); Red Eye(s) (2038); Swelling (2091)

Event Date 04/25/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2018 a patient (pt) from (b)(6) reported having difficulty removing a 1-day acuvue® moist® brand contact lens (cl) from the os (b)(6) 2018.Upon cl removal the pt experienced pain x 1-week, corneal irritation, redness, swelling and possibly an abrasion os.Multiple attempts were made to contact the pt for additional information, attempts were unsuccessful.On (b)(6) 2018 the pt reported the event occurred the end of (b)(6) 2018.The suspect os cl had "wavy" edges.Pt's eye care provider advised pt there was no corneal ulcer, but a "gouge" in the os.On 11jun2018 limited medical records were received: on (b)(6) 2018 presented with os redness, pain and irritation after cl removal on (b)(6) 2018.Chart indicates pt was examined (b)(6) 2018 by a physician's assistant who noted "dots" os after staining.Sle: corneal superior nasal feathered infiltrate; loose flap of epithelium; pressure os:17 mmhg.Os corneal ulcer, possible acanthamoeba, fungal infection due to appearance.Pt is a daily cl wearer, showers in lenses with exposure to tap water.Treatment: tobramycin ung qhs; zymar 1 gtt q 30 min x 24 hours then q 1-hour overnight os.Pt was referred emergently to an ophthalmologist.On (b)(6) 2018 follow-up (fu): pt c/o os pain, keeps os closed, redness, photophobia, reports less blur today.Sle: conjunctiva: gr 2 diffuse injected; cornea <4 mm v/h area ulcer with staining, infiltrate, striae, trace epi flap superiorly.Tonometry pressure os: 19 mmhg.Treatment: tobramycin ung qhs os, zymar 1 drop q 30 min.On (b)(6) 2018 fu: pt c/o pain, keeping eye closed, more swollen after "cyclo" drops yesterday.Exam: os: conj: gr 2 diffuse injected, concentrated at nasal limbus; cornea: 3 mm v/4.5 mm h striated ulcer with staining, infiltrative, 2-3 mm epi flap superiorly; tonometry pressure: 22 mmhg.Corneal ulcer os.On (b)(6) 2018 fu: pt c/o pain, keeps os closed, more swelling after cyclo.Pt to see ophthalmologist today.Sle: conj: gr 2 diffuse injected, concentrated at nasal limbus.Continued from b.5: cornea: 3 mm v/4.5 h striated ulcer with staining, infiltrative, 2-3 mm epi flap superiorly.Pressure: 22 mmhg.Dx: corneal ulcer os, no changes since yesterday.Continue zymar q1h and tobramycin os.Fu appointment with ophthalmologist (b)(6) 2018: zymar gtts q 1 h, tobramycin ung hs, cyclogyl 1 drop bid os.On (b)(6) 2018 fu: os red, swollen, worsening past few days.Bcl off (b)(6) 2018.Muro 128 gtts x 1 week.Muro qhs tid os 3-10 may; d/c maxidex tid (b)(6); still using zymar tid os; at prn.Sle: injection, mild lid edema; conj: gr 2 injection all quads; limbus: gr 2 limbal injection 360; cornea: no stain, trace sup infiltrate; pressure os: 23 mmhg.Os debridement with specialist.D/c steroid and antibiotic.Start maxidex bid os; at bid.On (b)(6) 2018 fu: pt c/o red eye, feeling increased pressure, lid closed os.Conjunctiva: trace diffuse injection; cornea: trace superior and central infils; pressure: 20 mmhg.S/p corneal erosion episode; had debridement and bcl fu with specialist.Tobradex 0.3% 1 gtt tid x 3 days; 1 gtt bid x 3 days; then 1 gtt qd x 3 days os.On (b)(6) 2018 fu: os red eye, fbs occasionally.Sle: cornea: trace inferior and central infils; pressure: 19 mmhg.S/p corneal erosion episode.Complete tobradex taper.Avoid cl wear next few weeks, especially if eyes feel dry.At prn.F/u with specialist; rtc if worsens.No additional medical information has been received.The lot # was unknown and the suspect os lens was discarded.If any further relevant information is received, a supplemental report will be filed.Serious reportable event trends are reviewed quarterly in franchise management review meetings.

• Brand Name: 1-DAY ACUVUE MOIST
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. ¿ US; 7500 centurion parkway; jacksonville FL
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 7656599
• MDR Text Key: 112995594
• Report Number: 1057985-2018-00088
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): Y
• Reporter Country Code: CA
• PMA/PMN Number: N18033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 1DM
• Device Lot Number: UNK-1DM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 38 YR