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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ US ACUVUE VITA SOFT CONTACT LENS, DAILY WEAR

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JOHNSON & JOHNSON VISION CARE, INC. ¿ US ACUVUE VITA SOFT CONTACT LENS, DAILY WEAR Back to Search Results
Catalog Number ATL
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Corneal Ulcer (1796); Foreign Body Sensation in Eye (1869); Irritation (1941); Keratitis (1944); Pain (1994); Red Eye(s) (2038); Corneal Infiltrates (2231)
Event Date 01/25/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
On 09oct2020 a johnson and johnson sales representative in canada sent an email advising an eye care provider (ecp) had a patient who experienced issues while wearing the acuvue® vita¿ brand contact lenses. On 20oct2020 additional information was provided by the ecp¿s representative. The pt was seen on (b)(6) 2020 and diagnosed with od infiltrative keratitis and od bacterial corneal ulcer. The representative reported pt symptoms of foreign body sensation, redness, pain, and soreness and initially self-treated with visine eye drops. The pt reported no change in the contact lens solution, biotrue. The pt was prescribed lotemax 1 drop q2h for 2 days, then qid until follow-up. The pt was also prescribed vigamox eye drops q2h for 2 days, then qid until follow-up. Follow-up visit 29jan2020: the record reflects the infiltrates and staining od continued; diagnosis provided was infiltrative keratitis od. The pt was advised with continue lotemax and vigamox od eye drops (no frequency noted) until follow-up visit. On (b)(6) 2020 the pt presented for follow-up and had slight infiltrates in od. The pt was advised to continue lotemax qid for 2 weeks, then bid for 1 week, then ok to resume contact lens wear. No return visit is noted. No additional information is expected. The lot number of the suspect product is not available. The suspect od contact lens was discarded. No analysis could be conducted. If any further relevant information is received, a supplemental report will be filed.
 
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Brand NameACUVUE VITA
Type of DeviceSOFT CONTACT LENS, DAILY 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 Key10812438
MDR Text Key217643067
Report Number1057985-2020-00058
Device Sequence Number1
Product Code LPL
Combination Product (y/n)Y
Reporter Country CodeCA
PMA/PMN Number
K160212
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 11/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberATL
Device Lot NumberUNK-ATL
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/20/2020
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?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/09/2020 Patient Sequence Number: 1
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