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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. - US ACUVUE OASYS 1-DAY FOR ASTIGMATISM WITH HYDRALUXE TECHNOLOGY; LENSES, SOFT CONTACT, DAILY WEAR

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JOHNSON & JOHNSON VISION CARE, INC. - US ACUVUE OASYS 1-DAY FOR ASTIGMATISM WITH HYDRALUXE TECHNOLOGY; LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Catalog Number TAS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Conjunctivitis (1784); Corneal Scar (1793); Erythema (1840); Keratitis (1944); Visual Disturbances (2140); Corneal Infiltrates (2231); Eye Pain (4467)
Event Date 12/31/2019
Event Type  Injury  
Manufacturer Narrative
The suspect product was discarded.
 
Event Description
On (b)(6) 2021 a patient (pt) called to report a diagnosis of a ¿virus¿ in both eyes while wearing the acuvue® oasys® 1-day for astigmatism with hydraluxe¿ technology brand contact lens (cls).The eye care provider (ecp) advised the pt not to use the cls anymore.No additional information was provided.On 18jun2021 the pt provided additional information.The pt had discharge papers provided by the treating ophthalmologist which read, ¿bacterial keratitis and scar in the outside of the cornea, not affecting the vision in the os¿.The pt was prescribed moxifloxacin ophthalmic 1 drop qid os with an unknown treatment duration.The os event has resolved, but the pt has not returned to cls wear per the ecp recommendation.The pt will provide the medical report by email.The pt reports daily cls wear with a daily cls replacement schedule.On 21jun2021 the pt provided the medical report by email.Date of visit: (b)(6) 2020.Chief complaint: possible os eye infection, complains of photophobia and os eye pain.The pt may have had ¿os eye infection¿ since (b)(6) 2019, complains of eye pain, clear discharge, photophobia; pt began ciprofloxacin (b)(6) 2020 with some relief.Pt reports daily cls wear.Medications: ciprofloxacin 0.3%/dexamethasone 0.1% ear drops, 1 drop tid; ocuflox 0.3% eye drops, 1 drop q1h while awake os, prescribed (b)(6) 2020.Va os: 20/20-1; iop os: 8.Anterior exam os: lids, lashes, lacrimal: 1-2 + inj; conjunctiva: white and quiet; cornea: <1mm nasal central infiltrate; anterior chamber: deep and quiet.Assessment and plan: bacterial keratitis: (b)(6) 2020; prescribed: ocuflox 0.3% eye drops: (b)(6) 2020 , 1 drop every hour while awake os; no cl wear with acute infection; return in 1 week.Date of visit (b)(6) 2020: os cornea: scar, no epi defect.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 b00r8t2 was produced under normal conditions.The suspect os discarded.No additional evaluation can be conducted.If any further relevant information is received, a supplemental report will be filed.
 
Manufacturer Narrative
On (b)(6) 2021 during a file review it was noted that there was a date error on the initial mdr 1057985-2021-00143 submitted on (b)(6) 2021.In section a2, the patient¿s date of birth was noted as "(b)(6) 1973¿ but should be (b)(6) 1973.If any further relevant information is received, a supplemental report will be filed.
 
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Brand Name
ACUVUE OASYS 1-DAY FOR ASTIGMATISM WITH HYDRALUXE TECHNOLOGY
Type of Device
LENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
JOHNSON & JOHNSON VISION CARE, INC. - US
7500 centurion parkway
jacksonville FL 32256
MDR Report Key12169642
MDR Text Key277184915
Report Number1057985-2021-00143
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
PMA/PMN Number
K042275
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 07/27/2021
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 Expiration Date09/01/2023
Device Catalogue NumberTAS
Device Lot NumberB00R8T2
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/18/2021
Initial Date FDA Received07/14/2021
Supplement Dates Manufacturer Received07/19/2021
Supplement Dates FDA Received07/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention; Disability;
Patient Age46 YR
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