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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND 1-DAY ACUVUE TRUEYE (NARA A) LENSES, SOFT CONTACT, DAILY WEAR

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JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND 1-DAY ACUVUE TRUEYE (NARA A) LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Catalog Number 1D4
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Corneal Decompensation (1790); Corneal Scar (1793); Corneal Ulcer (1796); Hypopyon (1913); Keratitis (1944); Loss of Vision (2139)
Event Date 09/14/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
On (b)(6) 2019 a patient (pt) a diagnosis of an os corneal ulcer while wearing the 1-day acuvue® trueye® brand contact lenses (cls). On (b)(6) 2019 the pt reported os pain and removed the suspect lens. The pt presented to the emergency room (er) the following day due to continued os pain and discomfort. The er physician referred the pt to an ophthalmologist as soon as possible. The pt saw the ophthalmologist the same day and was advised ¿it was a very severe corneal ulcer from contact lens use. ¿ the pt was ¿prescribed a series of eye drops¿ (details not provided) to be applied every hour for 24 hours a day for a week. The ophthalmologist obtained cultures. The pt reported there is no vision in the os so the ophthalmologist referred the pt to a cornea specialist. The pt reported symptoms of headache and photophobia and wears an eye patch. The pt advised there will likely be a permanent loss of vision and will need a cornea transplant. On (b)(6) 2019 a call was placed to the pts treating ophthalmologist and additional information was provided: the pt was diagnosed with corneal ulcer and was seen in the office for 6 visits. The pt rescheduled an appointment for (b)(6) 2019, but missed the appointment and hasn¿t returned to the office. On (b)(6) 2019 a call was placed to the pts treating cornea specialist and additional medical information was requested, but nothing additional was provided. On 25oct2019 the pts medical records were received: date of visit: (b)(6) 2019; chief complaint (cc): ocular pain pt presented with os pain; os symptoms, pain 8/10, blurred vision, discharge, foreign body sensation, photophobia, redness and tearing for 2 days. Pt went to er and was referred for further evaluation. Pt is a contact lens wearer. No trauma. Eye exam os: vision os: lp; iop os: attempted, not achieved slit lamp exam os: conjunctiva: mucoid discharge; cornea: 6-7 mm central cu with a 1. 5 mm hypopyon, ulcer edges and base are necrotic with a modest loss of tissue; anterior chamber: hypopyon, ac reactive, fibrin in ac tests: corneal scraping os for cultures of central corneal ulcer, proparacaine drops for anesthesia, no complications, pt tolerated well, pt to return for re-eval next day. Impression/plan: central cu os, hypopyon os. Started fortified vancomycin and tobramycin q15min for the first 4 hours and every hour thereafter. Started atropine and combigan. Concern that with the tissue necrosis and thinning that perforation may occur. Possible pseudomonas. On (b)(6) 2019 fu office visit: cc: fu central cu os evaluated on (b)(6) 2019. Pt fu, pt reports no pain, has blurred vision. Lab results (not legible); pt feels os is unchanged some pain and irritation. Pt using vanco and tobramycin drops q 15 min for 1st 4 hours and q 1 h thereafter, combigan and atropine qid os. Exam os: va: hm ph: ni; iop: 6; conjunctiva: mucoid discharge. Slit lamp exam os: cornea: 6-7 mm central cu with a 1. 5 mm hypopyon. Ulcer edges and base are necrotic with a modest loss of tissue; ac: hypopyon, ac reactive, fibrin in ac. No real change, overall seems to be stable compared to yesterday. Will keep up meds and recheck in 48 hours. Culture negative so far; gm + pmn and g-. Pt should be scheduled for blood draw study. On (b)(6) 2019 fu visit: cc: fu central cu os. Pt seen for further evaluation and management, possible blood draw for study mentioned. No pain, redness and blurred vision. Os exam; va: cf @ 1ft; iop: attempted, not achieved; conjunctiva: mucoid discharge slit lamp os: 6-7 mm central cu with a 1. 5 mm hypopyon. Ulcer edges and base are necrotic with a modest loss of tissue; ac: hypopyon, ac reactive, fibrin in ac impression/plan: central corneal ulcer os, hypopyon os improved with cleaning of the base with less ac rxn. Ac hypopyon is almost gone. Keep up meds and recheck on monday. On (b)(6) 2019 fu visit: cc: fu central corneal ulcer os. Today pt reports pain 7/10; pt reports throbbing pain around os, redness, tearing, and photophobia. Os eye exam: va: hm; iop: attempted, not achieved; conjunctival mucoid discharge. Slit lamp os: 6-7 mm central cu with a 1. 5 mm hypopyon. Ulcer edges and base are necrotic with a modest loss of tissue; ac: os: hypopyon, ac reactive, fibrin in ac. Impression/plan: central corneal ulcer os, hypopyon os, 6. 5 x 4. 5 mm necrotic based ulcer with some healing along edges. Thinning to 40% nl at one point. No hypopyon. To start to taper q day ¿ check on thur. To taper vanco and tobra 1x/a day. Reduce atropine and combigan to bid. On (b)(6) 2019 fu visit: cc: fu central corneal ulcer os. Today pt reports 7/10 pain; pt is having pain, headache, blurred vision and redness. Pt states getting bad headaches on the left side of the face around the eye. Os eye exam: va: hm; iop: attempted, not achieved; conjunctiva: mucoid discharge slit lamp os: corneal infiltrate, corneal stromal thinning, and a 6-7 mm central cu with a 1. 5 mm hypopyon. Ulcer edges and base are necrotic with a modest loss of tissue. Slit lamp exam of ac: os: ac reaction and hypopyon. Impression/plan: central corneal ulcer os, hypopyon os. Gradual migration to epit. To reduce antx to q6h and finish atropine and combigan. Check in 1 week. On (b)(6) 2019 fu visit: cc: central corneal ulcer os today the pt reports no pain, blurred vision. Pt still gets headache and has been using tylenol, extra tearing os the past few days. Vision is still ou, still using vancomycin and tobramycin os. Eye exam os: va: hm ph: ni; iop: 14; conjunctiva: mucoid discharge. Slit lamp exam os: corneal infiltrate, corneal stromal thinning, and a 6-7 mm central cu with a 1. 5 mm hypopyon. Ulcer edges and base are necrotic with a modest loss of tissue; ac reaction and hypopyon. Impression/plan: central corneal ulcer os, hypopyon os severe ha and pain this am. Defect unchanged with quiet area surrounding the defect. Ac and surrounding sclera with min injection or reaction. To finish fortifieds tid and then change to oflox tid. Prescription: ofloxacin 0. 3% eye drops, 1 gtt os tid. On (b)(6) 2019 fu visit: cc: red eye. Pt c/o red eye, pain, photophobia, tearing and headache. Pt previously seen by another ecp and taken the following treatments in the past: antibiotic drops, vancomycin, tobramycin, atropine, and combigan eye exam os: va: hm slit lamp exam os: 6x6 mm central ulcer with epi defect, severe k edema, no apparent thinning, no perforation impression/plan: central corneal ulcer os, counseling regarding the following: sever corneal ulcer os, now present approx. 1 month. Previously followed by prior ecp, but lost to follow up x 1 week after practice dissolution. Pt counseled that seeing a corneal specialist is critical for preservation of the globe. Increase ofloxacin to qid. Pt referred to cornea specialists immediately. On (b)(6) 2019 (cornea specialist): microbial keratitis, ? sterile, seems to have improved compared to previous ecp notes as there had been a hypopyon. Fu 2 days and at that time may consider slowly starting steroid drops, changing antibiotic drops or perhaps consideration of tarsorrhaphy. Any sign of ulcer progressing to sclera or towards perforation and might have to consider therapeutic penetrating keratoplasty. Cc: np corneal ulcer os / referral. History: pt c/o corneal ulcer os about 1 month ago. He wears daily scl ou, pt may have extended them for two days max. He c/o photophobia, tearing, discharge, pain with blurred vision. He is taking tylenol extra strength 500 mg tid po. Pt wearing a black patch over os to help with light sensitivity. Omeds: ofloxacin qid os. Visual acuity with glasses: os: hm; iop os: 9. Slit lamp exam os: lids, lashes and lacrimal os: conjunctival injection. Lids, lacrima, conjunctiva: more pronounced inferiorly. Cornea: large necrotic infiltrate centrally with 1mm ring of epithelialization, 1. 5mm. Clear cornea inferiorly, significant edema centrally with few areas of mild thinning but no significant thinning. Ac os: no hypopyon. On (b)(6) 2019 cornea specialist: cc: 5 day fu to microbial keratitis od / prev ecp. Meds: ofloxacin qid os. Visual acuity with glasses os: hm; visual acuity with pinhole: hm. Iop: os ¿ 13 slit lamp exam os: lids, lashes and lacrimal os: conjunctival injection. Lids, lacrima, conjunctiva: more pronounced inferiorly. Cornea: large necrotic infiltrate centrally with 1mm ring of epithelialization, 1. 5mm clear cornea inferiorly, significant edema centrally with few areas of mild thinning but no significant thinning. Ac os: no hypopyon. On (b)(6) 2019 additional information was provided by the pt: pt saw cornea specialist yesterday and reports ¿the infection is finally gone after 7 weeks. ¿ all treatment was discontinued for a week and did not prescribe any new treatment. Pt has a fu appointment next week. Pt reported if everything is ok next week, will have a discussion regarding the transplant with the ecp. 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 5455480111 was produced under normal conditions. The suspect os contact lens was discarded. No evaluation can be conducted. If any further relevant information is received, a supplemental report will be filed.
 
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Brand Name1-DAY ACUVUE TRUEYE (NARA A)
Type of DeviceLENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND
one technological park plassey
limerick
EI
Manufacturer Contact
rose harrell
7500 centurion parkway
jacksonville, FL 32256
9044433364
MDR Report Key9293403
MDR Text Key184874105
Report Number9617710-2019-00046
Device Sequence Number1
Product Code LPL
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K073485
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number1D4
Device Lot Number5455480111
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/06/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/16/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 11/07/2019 Patient Sequence Number: 1
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