• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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); Dry Eye(s) (1814); Red Eye(s) (2038); Eye Pain (4467)
Event Date 10/22/2021
Event Type  Injury  
Event Description
On 26-nov-2021 an eye care provider (ecp) in the (b)(6) called to report a patient (pt) went to the hospital and was diagnosed with 2 eye ulcers while wearing the acuvue® oasys 1-day with hydraluxe® technology brand contact lens cls. The exact date is unknown. No additional information was provided. On 02-dec-2021 the ecp reported the pt still wants to wear the lenses, but the ecp doesn¿t recommend that for the pt. The pt doesn¿t want to wear the lenses from the suspect lot number related to this event. On 15-dec-2021 additional medical information was provided by a representative at the pts reporting ecp office. The pt was seen at the hospital on (b)(6) 2021 after symptoms of redness and pain ou presented. The pt was diagnosed with corneal ulcer ou. The corneas were scrapped and the sample was sent to the lab for testing. The ou corneal ulcers were not infectious. The pt was prescribed oftaquix 1 drop hourly in both eyes until (b)(6) 2021. The pt was also prescribed an unknown eye drop for dry eye and advised to discontinue cls wear. The pts eyes are currently fine with no permanent damage or loss of visual acuity. The manager will discuss release of additional medical information from the hospital treatment with the pt and advise if any additional information will be provided. 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 5270910109 was produced under normal conditions. The suspect cls for the od was discarded. No additional evaluation can be conducted. This report is for the pts od event. The event for the pts os will be provided in a separate report. If any further relevant information is received, a supplemental report will be filed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
helene aguilar
7500 centurion parkway
jacksonville, FL 32256
9044433835
MDR Report Key13027646
MDR Text Key286052802
Report Number1057985-2021-00178
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K042275
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 12/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberTSP
Device Lot Number5270910109
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/26/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/10/2021
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: 12/17/2021 Patient Sequence Number: 1
-
-