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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 WITH HYDRALUXE¿ TECHNOLOGY LENSES, SOFT CONTACT, DAILY WEAR

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JOHNSON & JOHNSON VISION CARE, INC. - US ACUVUE OASYS®1 DAY WITH HYDRALUXE¿ TECHNOLOGY LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Catalog Number TSP
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Corneal Edema (1791); Corneal Scar (1793); Corneal Ulcer (1796); Foreign Body Sensation in Eye (1869); Keratitis (1944); Red Eye(s) (2038); Blurred Vision (2137); Visual Disturbances (2140); Eye Pain (4467); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 10/06/2021
Event Type  Injury  
Manufacturer Narrative
The suspect os cls was discarded.
 
Event Description
On (b)(6) 2021 a representative at an eye care provider (ecp) in (b)(6) called to report a patient (pt) experienced os redness and foreign body sensation on (b)(6) 2021 while wearing an acuvue oasys®1 day with hydraluxe¿ technology brand contact lens (cls). The pt developed os eye pain after the os suspect cls was removed which currently continues. The pt will visit an ecp on (b)(6) 2021. On 08oct2021 the pt provided additional information. The pt reports current ¿cloudiness in white, for which cannot see at all¿. On (b)(6) 2021 the pt presented to an ecp and was diagnosed with ¿bacteria in keratitis¿. The pt was advised to discontinue cls wear. On (b)(6) 2021, on a return ecp visit, fluorometholone eye drops, vegamox eye drops and tarvid eye ointment were prescribed. A medical interview was requested for additional medical information. On (b)(6) 2021 an ecp at the pts treating eye clinic provided additional information. Diagnosis: probably bacterial keratitis. Seriousness: the pt was not able to see considerably, the event was considered serious. On the return visit (date not provided) some improvement was observed since the initial visit. A return visit is planned (no date was provided). On 13oct2021 the pt provided additional information. The pt advised the redness is better. The pt can also see better than before. On (b)(6) 2021 the pt returned for a follow-up visit and was instructed to return on (b)(6) 2021. Hyaluronic acid eye drops 0. 1% qid was prescribed. The pt continues to use the previously prescribed medications. No additional medical information has been received. The os lot number is unknown. The suspect os cls was discarded. No additional evaluation can be conducted. If any further relevant information is received, a supplemental report will be filed.
 
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Brand NameACUVUE OASYS®1 DAY WITH HYDRALUXE¿ TECHNOLOGY
Type of DeviceLENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
JOHNSON & JOHNSON VISION CARE, INC. - US
7500 centurion parkway
jacksonville FL 32256
Manufacturer Contact
richard holmes
7500 centurion parkway
jacksonville, FL 32256
9548020487
MDR Report Key12712009
MDR Text Key278864234
Report Number1057985-2021-00164
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K042275
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 05/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberTSP
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received05/06/2022
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? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/28/2021 Patient Sequence Number: 1
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