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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 Bacterial Infection (1735); Conjunctivitis (1784); Irritation (1941); Red Eye(s) (2038)
Event Date 11/23/2020
Event Type  Injury  
Manufacturer Narrative
Evaluation codes: (b)(4).Initial reporter's phone number: (b)(6).
 
Event Description
On (b)(6) 2020, an eye care provider (ecp) in (b)(6) reported a patient (pt) experienced irritation (unspecified eye) on (b)(6) 2020 while wearing the acuvue® oasys® brand contact lenses.The pt¿s ¿eye was not okay¿ after removal of the suspect lens.The pt presented to the ecp with red eye (unspecified eye), and the pt was prescribed ciprofloxacin eye drops to use 3 times a day for 7 days.The ecp has not re-examined the eye but reported ¿it seems okay now.¿ no further information was provided.On (b)(6) 2020, a call was received from the ecp with additional information.The ecp reported the event occurred on both eyes.The pt was diagnosed with ¿suspected bacterial conjunctivitis.¿ no further information was provided.On 10dec2020, a call was placed to the ecp and additional information was received.The ecp reported the pt did not tolerate the lenses well, so the ecp prescribed the pt ciprofloxacin eye drops to use 3 times a day for 7 days to treat bacterial conjunctivitis.The pt has not returned to the ecp for follow-up.The ecp is not able to confirm the pt¿s current eye condition or the diagnosis.The ecp refused to provide any additional information.No additional information has been received.The pt refused to return the suspect contact lenses for evaluation.The lot number is unknown.No further investigation can be conducted at this time.This report is for the os event.A separate report will be filed for the od event.If any further relevant information is received, a supplemental report will be filed.
 
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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
Manufacturer Contact
rose harrell
7500 centurion parkway
jacksonville, FL 32256
9044433364
MDR Report Key11038701
MDR Text Key226777488
Report Number1057985-2020-00075
Device Sequence Number1
Product Code LPM
Combination Product (y/n)Y
Reporter Country CodeAS
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 12/18/2020
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
Device Lot NumberUNK-PH
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/09/2020
Initial Date FDA Received12/18/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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