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U.S. Department of Health and Human Services

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

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JOHNSON & JOHNSON VISION CARE, INC. - US ACUVUE OASYS FOR ASTIGMATISM; LENSES, SOFT CONTACT, EXTENDED WEAR Back to Search Results
Catalog Number CYP
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Corneal Ulcer (1796); Red Eye(s) (2038); Eye Pain (4467)
Event Date 12/01/2020
Event Type  Injury  
Manufacturer Narrative
Suspect product discarded.
 
Event Description
On (b)(6) 2021, an eye care provider (ecp) in spain reported a patient (pt) was diagnosed with a corneal ulcer od in (b)(6) 2020 while wearing the acuvue® oasys® for astigmatism brand contact lens (cl).The pt experienced discomfort and redness after a period of cl wear.The pt sought medical attention (unknown date) and was diagnosed with a corneal ulcer od and prescribed tobradex eye drops (unknown frequency, dosage, duration).No further information was provided.On 19jan2021, additional information was provided by the reporting ecp.The pt was diagnosed with a ¿bacterial ulcer.¿ the issues began after 2-3 days of cl use.The pt did not notice any issues with the cl lenses.The ecp reported the pt has dry eyes and frequently uses artificial tears.The exact location of the ulcer is unknown.The pt has not returned to cl wear.The ecp reported the pt did not have any permanent damage or permanent loss of visual acuity.No further information was provided.On 20jan2021, additional information was provided by the reporting ecp.The pt was prescribed tobradex tid for 5 days.The ecp reported the pt has finished the treatment and currently feels fine.The location of the ulcer was inferior temporal.No further information was provided.On 27jan2021, additional information was provided by a representative of the reporting ecp.The medical report (date of visit not provided) from the treating ophthalmologist confirmed the pt was prescribed tobradex tid for 5 days.The diagnosis was od bacterial corneal ulcer located inferior temporal.The representative reported it was unclear if the bacteria was caused by the cl or by the pts hygiene or make-up.The pt recovered after 5 days with no further issues, no permanent damage, and no visual acuity problems.The pt has not returned for follow-up and it is unknown if the pt has returned to cl wear.No further information was provided.On 03feb2021, the reporting ecp representative clarified the pt provided the information from the medical report that the pt received from the treating ophthalmologist.The date of the visit was not provided.The treating ophthalmologist contact information is unknown.The pt has not returned for follow-up and no further medical information is expected.The suspect od cl has been discarded.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 b00rc04 was produced under normal conditions.If any further relevant information is received, a supplemental report will be filed.
 
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Brand Name
ACUVUE OASYS FOR ASTIGMATISM
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
rose harrell
7500 centurion parkway
jacksonville, FL 32256
9044433647
MDR Report Key11275904
MDR Text Key230681729
Report Number1057985-2021-00108
Device Sequence Number1
Product Code LPM
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
P040045
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/03/2021
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 Date10/01/2023
Device Catalogue NumberCYP
Device Lot NumberB00RC04
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/12/2021
Initial Date FDA Received02/03/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/13/2018
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; Required Intervention;
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