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U.S. Department of Health and Human Services

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

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JOHNSON & JOHNSON VISION CARE, INC. - US ACUVUE® OASYS®; LENSES, SOFT CONTACT, EXTENDED WEAR Back to Search Results
Catalog Number PH
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cataract (1766); Corneal Scar (1793); Corneal Ulcer (1796); Keratitis (1944); Red Eye(s) (2038); Blurred Vision (2137); Eye Infections (4466); Eye Pain (4467)
Event Date 10/18/2021
Event Type  Injury  
Event Description
On(b)(6) 2023, a patient (pt) reported a diagnosis of corneal ulcer in the left eye (os) after sleeping in acuvue® oasys® contact lenses (cls) "for a few days while cleaning out a dusty, dirty place" in october 2021.The pt was prescribed an antibiotic eye drop (name and frequency of use not provided) from a compound pharmacy and stated the ulcer healed with no permanent damage.The pt did not know the location of the ulcer on the cornea.The pt was first seen by an eye care professional (ecp) who prescribed the cls and was later referred to an ophthalmologist.On (b)(6) 2023, a call was placed to the pt¿s treating ecp¿s office.The pt was seen on (b)(6) 2021 and was diagnosed with an os corneal ulcer.The pt was prescribed ofloxacin 1 drop every 2 hours (q2h) for 2 days.The pt was seen for follow-up visit on (b)(6) 2021, advised to discontinue cl wear until instructed, and report any changes.The pt was directed to continue eye drops as directed and referred to a corneal specialist.On (b)(6) 2023, a call was placed to the corneal specialist's office.(b)(6) 2021 initial visit: the pt was seen on referral with complaints of eye irritation and a "sore in the eye." the pt was diagnosed with os keratitis, infectious, with slow response to ofloxacin, corneal ulcer, peripheral os, and cataract nuclear sclerosis.The pt was prescribed tobramycin 14 ml/g and fortified cefazolin 50mg, ¿switch drops every 1/2 hour while awake.¿ the pt was instructed to use both drops every 5 minutes for the first hour when waking as a loading dose and follow-up (f/u) in 1 day.(b)(6) 2021 f/u visit: the pt presented with complaints of photophobia and sore eye.The pt reported that the fortified cefazolin was not going to be available from the pharmacy until today, (b)(6) 2021.The pt was advised to begin using medication as directed.(b)(6) 2021 f/u visit: the pt started the medications and was instructed to f/u the next day.24oct2021 f/u visit: the pt reported the eye was "slightly better" after using the meds.The epithelial defect was "down from 3mm to 1mm." the pt was instructed to continue medications as directed.(b)(6) 2021 f/u visit: improving, still using meds q1h while awake and q2h during sleeping hours.The pt was instructed to continue medications as directed.(b)(6) 2021 f/u visit: improving, redness from the eye drops.The pt was instructed to continue medications q1h while awake.(b)(6) 2021 f/u visit: the pt complained os still hurt, and still had ¿fuzzy vision.¿ the pt was instructed to continue medication q1h while awake with ¿loading dose each morning.¿ (b)(6) 2021 f/u visit: the pt was given a sample of besivance to use four times a day (qid), and stated "feels smaller, less light sensitivity but still blurry vision." the pt was instructed to continue medications as directed and was given 1 drop lotemax while in the office.(b)(6) 2021 f/u visit: the pt was instructed to continue with tobramycin and cefazolin q1h while awake and q2h during sleeping hours; besivance qid.Dose of lotemax was given to the pt in office.(b)(6) 2021 f/u visit: the pt reported compliance with tobramycin, cefazolin, and besivance.The pt reported feeling much better "but can feel it and eye is very red." the pt was instructed to decrease tobramycin from q1h to qid; besivance qid; lotemax qid.On (b)(6) 2023, an employee at the corneal specialist's office provided additional information.(b)(6) 2021 f/u visit: the pt reported noted improvement; good compliance with tobramycin, cefazolin, besivance and lotemax.The exam showed os stable, and pt was instructed to decrease fortified tobramycin to q2h, cefazolin qid; besivance qid; lotemax at bedtime.(b)(6) 2021 f/u visit: the pt was instructed to decrease fortified tobramycin to qid, ¿cpm;¿ continue lotemax at bedtime; discontinue cefazolin and besivance.(b)(6) 2021 f/u visit: the pt complained of mild scratchy redness, using over-the-counter gentile gel, and vision "seems stable." the pt was instructed to discontinue all drops and only wear cl daily wear as needed, trying 1 hour at a time.The pt was warned not to sleep in cls.The pt's ulcer healed with a corneal scar.A culture was negative for aerobic organisms; other results pending.The pt was instructed to return next year for a routine eye exam.No additional medical information has been received.The suspect os lot number is unknown.The os suspect cl was discarded.No additional evaluation can be conducted.If any further relevant information is received, a supplemental report will be filed.
 
Manufacturer Narrative
Suspect os lens was discarded.
 
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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 32256
Manufacturer Contact
helene aguilar
7500 centurion parkway
jacksonville, FL 32256
9047429918
MDR Report Key17034766
MDR Text Key316297782
Report Number1057985-2023-00036
Device Sequence Number1
Product Code LPM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P040045
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 05/31/2023
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 NumberPH
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/08/2023
Initial Date FDA Received05/31/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other; Disability; Required Intervention;
Patient SexFemale
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