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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE - IRELAND ACUVUE OASYS®1 DAY WITH HYDRALUXE¿ TECHNOLOGY LENSES, SOFT CONTACT, DAILY WEAR

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JOHNSON & JOHNSON VISION CARE - IRELAND 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 Corneal Ulcer (1796); Red Eye(s) (2038)
Event Date 10/01/2021
Event Type  Injury  
Manufacturer Narrative
Suspect product discarded.
 
Event Description
On (b)(6) 2021 a patient¿s (pt) family member in (b)(6) called to report od redness that occurred about 1 to 2 weeks ago ((b)(6) 2021) while wearing an acuvue® oasys 1-day with hydraluxe¿ technology brand contact lens (cls). The pt went to see an eye care provider (ecp) who diagnosed an ¿eye ulcer¿ about a week ago. The pt was prescribed an unknown eye drop and advised not to wear an od cls. The pt reported the od event has not resolved. On (b)(6) 2021 a call was placed to the pts prescribing ecp who advised the suspect od contact lens was discarded. No additional medical information was provided. The date of the event is reported as (b)(6) 2021. Multiple calls were placed to the pts family member for additional medical information, but nothing additional 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 5652750111 was produced under normal conditions. The suspect od 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 - IRELAND
1 technological park plassey
limerick LK130 01
EI LK13001
Manufacturer Contact
richard holmes
7500 centurion parkway
jacksonville, FL 32256
9548020487
MDR Report Key12782387
MDR Text Key282126518
Report Number1057985-2021-00168
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K042275
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 11/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberTSP
Device Lot Number5652750111
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/19/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/08/2021
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: 11/09/2021 Patient Sequence Number: 1
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