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U.S. Department of Health and Human Services

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

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JOHNSON & JOHNSON VISION CARE - IRELAND 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 Bacterial Infection (1735); Conjunctivitis (1784); Corneal Scar (1793); Corneal Ulcer (1796); Erythema (1840); Eye Injury (1845); Itching Sensation (1943); Keratitis (1944); Local Reaction (2035); Red Eye(s) (2038); Blurred Vision (2137); Visual Disturbances (2140); Corneal Infiltrates (2231); Eye Pain (4467)
Event Date 07/10/2023
Event Type  Injury  
Manufacturer Narrative
H3 other text : suspect product requested, not returned.
 
Event Description
On 28nov2023, an email was received from an online retailer advising that a patient (pt) in the united kingdom experienced right eye (od) redness and itching with a swollen eyelid on the first day of wearing acuvue® oasys® brand contact lenses (cls) (date not provided).The pt had sharp pain with cloudy vision in the od that worsened by day two of cl wear.The pt has a history of diabetes.The pt visited an eye care professional (ecp), was diagnosed with pseudomonas keratitis with corneal ulcer in the od, and was prescribed moxifloxacin, gentamicin and "dexafree" eye drops (dosage and frequency not provided).The online retailer advised that the pt's ophthalmology report dated (b)(6) 2023 states that the eye is now "white and comfortable" with no corneal epithelial defect.There is however corneal scarring.Vision in od with pinhole 6/9.5.Treatment is on-going with next appointment due on (b)(6) 2023.On 05dec2023, the online retailer called to provide additional information.The pt is an experienced wearer who inserted a new lens from a sealed blister package and experienced red, sore eye and eyelid and blurry vision after "a while of use." the pt removed the lens because of the issue and sought medical attention.The pt was diagnosed with keratitis and a corneal ulcer in the od.The event occurred on 10jul2023, on the first day of use.The pt was prescribed, and is still using: gentamicin 0.3%, 1 drop 6 times a day; moxifloxacin, 1 drop 6 times a day; and dexamethasone, 1 drop 4 times a day.The pt has not returned to cl wear.The pt does not sleep while wearing cls and "did not have any other unusual events while wearing the lenses like bathing, showering, swimming, or coming into contact with water." on 05dec2023, the online retailer provided additional information via email.The pt uses a multipurpose solution and advised, "i always soak the lenses in the case before first use overnight (minimum 6 hours)." copies of the pt's medical reports were also attached: visit date 11jul2023 referral: pt has a history of diabetes and cl wear.Pt presented with red eye that started last night.Pt has sharp pain in od, itching, swelling of eyelid, tenderness under the eye and hazy/foggy vision.Visit date 12jul2023 symptoms: od pain, had antibiotics but now cannot see at all from the eye overnight history: pt uses soft cls, pt advises cannot see anything with the od, it hurts.Vision got worse after using chloramphenicol eye drops yesterday.Examination: od red with yellow discharge.Corneal ulcer at 6 o¿clock almost covering the pupil, hazy anterior chamber (ac).Treatment: referred to ophthalmology targeted history: started with od eye infection on monday night, called general practitioner yesterday and was prescribed chloramphenicol, now unable to see from the eye, all blurred.Visit date 19jul2023 problems: od cl-related corneal ulcer plan: reduce "moxi" to 6 times a day, add "dexafree" 4 times a day, review friday visit date 28jul2023 problems: od cl-related corneal ulcer va: od 0.80 (6/38) with glasses (0.72 (6/30) with pinhole) comment/plan: od contact lens related keratitis (clrk) reports eye feeling better and less painful on "cyclo bd." on examination: od moderate conjunctival injection; resolving clrk; ulcer 2.4 mm size in inferior cornea, superficial keratitis at edges and more in middle.Visit date 07aug2023 problems: od cl-related corneal ulcer va: od "0.20 (6/9.5)" with glasses plan: acute cornea clinic; od clrk; added gentamicin 0.3% "qds," still on moxifloxacin 6 times a day and dexamethasone "qds." feeling much better today, slightly irritable and photosensitive but improving.Pt has spoken to optician as this started the same day a new cl was inserted.Pt has not worn cls throughout treatment.On examination: od inferior conjunctival injection.Inferior corneal ulcer ¿ infiltrate 2.0x2.5mm, epithelial defect 1.3x1.8mm ¿ much better than measurements last week.Ac deep and quiet ¿ improvement.Impression: significant improvement with addition of gentamicin plan: continue all current drops, review in cornea clinic in 1 week or immediately if any worsening symptoms follow-up appointment scheduled 14aug2023 visit date 17aug2023 va: od with glasses 0.10 diagnosis: 1.Od clrk 2.Corneal scrape pseudomonas current treatment: 1.Gentamicin drops 0.3% 6 times a day to od 2.Moxifloxacin drops 6 times a day to od 3.Dexamethasone drops 4 times a day to od doctors note: pt reports vision is still hazy but much improved, redness and cloudiness in the od has resolved and irritation is settling down.Pt reports photosensitive in the morning, but improves almost immediately.On examination: mild inferior injection in od, 2.5mmx1.4mm infiltrate inferiorly on the cornea with overlying 1.6mm partial epithelial defect.Ac is deep and quiet.The impression is that the clrk is improving.Pt advised to reduce drops: gentamicin to 3 times a day, moxifloxacin to 3 times a day and dexamethasone to 3 times a day.Pt to be seen in 2 weeks.Visit date 31aug2023 va: od 0.10 pt seen for follow-up of od cl-related pseudomonas keratitis.Symptoms continue to improve and clinical appearance has improved.Pt to reduce gentamicin and moxifloxacin drops to once a day and to continue with dexamethasone 3 times a day.Pt to be seen in "about a month." visit date 28sep2023 va: od 0.24 pinhole 0.20 diagnosis: od clrk (pseudomonas) current treatment: 1.Dexamethasone drops 3 times a day od 2.Gentamicin drops twice a day od 3.Moxifloxacin twice a day od comments: pt feels progress has slowed and vision is cloudy in the od but otherwise comfortable.Pt says vision is no worse than previously, is not improving as the rate it previously did.Pt has not used cls.Pt stated has been taking dexamethasone 4 times a day and gentamicin and moxifloxacin twice a day in the od despite a different plan from the clinic last week.On examination, eye appears white and ac is deep and quiet.There is a 3.2 x 3.3mm area of mildly thin cornea with a deeper scar, no epithelial defect present and intraocular pressure is stable in od.Pt was reviewed in clinic and the impression is that the infection has settled down and now dealing with the scarring following the corneal ulcer.The plan is to stop moxifloxacin and gentamicin drops, continue dexamethasone drops to od 3 times a day and follow-up in one month.Pt advised to not wear cls.No additional 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 l005x48 was produced under normal conditions.The od suspect cls are not available for return.No additional evaluation can be performed.If any further relevant information is received, a supplemental report will be filed, as appropriate.
 
Manufacturer Narrative
On 20dec2023, a call was received from the online retailer.There is "no outcome" or medical report for the patient's (pt's) follow-up visit one month after (b)(6) 2023.The pt is still under the care of the ophthalmologist and will not soon wear lenses again.No additional medical information has been received.No additional information is expected.If any further relevant information is received, a supplemental report will be filed, as appropriate.
 
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Brand Name
ACUVUE® OASYS®
Type of Device
LENSES, SOFT CONTACT, EXTENDED WEAR
Manufacturer (Section D)
JOHNSON & JOHNSON VISION CARE - IRELAND
1 technological park plassey
limerick LK130 01
EI  LK13001
Manufacturer Contact
helene aguilar
7500 centurion parkway
jacksonville, FL 32256
9047429918
MDR Report Key18360463
MDR Text Key330934963
Report Number1057985-2023-00096
Device Sequence Number1
Product Code LPM
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
P040045
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/02/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Catalogue NumberPH
Device Lot NumberL005X48
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received12/20/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/25/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
RENU MULTIPURPOSE SOLUTION
Patient Outcome(s) Disability; Required Intervention;
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