• 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, INC. ¿ LIMERICK ACUVUE OASYS1 DAY WITH HYDRALUXE TECHNOLOGY LENSES, SOFT CONTACT

  • 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, INC. ¿ LIMERICK ACUVUE OASYS1 DAY WITH HYDRALUXE TECHNOLOGY LENSES, SOFT CONTACT Back to Search Results
Catalog Number TSP
Device Problem No Apparent Adverse Event (3189)
Patient Problems Bacterial Infection (1735); Red Eye(s) (2038); Swelling (2091); Discomfort (2330)
Event Type  Injury  
Manufacturer Narrative
(b)(4). (b)(6).
 
Event Description
On (b)(6) 2018 a patient (pt) in (b)(6) reported discomfort (affected eye not provided) in (b)(6) 2017 while wearing the acuvue oasys 1 day brand contact lens. The pt reported wearing the suspect lens 30 to 60 minutes. The suspect lens was removed and the pt noticed the lens was torn. The pt reported the redness seemed to resolve the next day. The pt wore glasses. The pt developed eye swelling a few days after the event. On (b)(6) 2018 the pt went to an eye care provider (ecp) and was diagnosed with ¿bacteria in the eye and staining¿. The pt was prescribed eye drops, but refused to provide the name or frequency of the treatment. The pt reported the eye swelling is persisting. The pt refused to provide any additional medical information and refused the medical interview. No additional medical information was provided and no additional information is expected. 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 5523900106 was produced under normal conditions. The suspect product was discarded. If additional information is received it will be reported within 30 days of receipt. Serious reportable event trends are reviewed quarterly in franchise management review meetings.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameACUVUE OASYS1 DAY WITH HYDRALUXE TECHNOLOGY
Type of DeviceLENSES, SOFT CONTACT
Manufacturer (Section D)
JOHNSON & JOHNSON VISION CARE, INC. ¿ LIMERICK
one technological park plassey
limerick
EI
Manufacturer Contact
rose harrell
7500 centurion parkway
jacksonville, FL 32256
9044433364
MDR Report Key7253007
MDR Text Key99589001
Report Number9617710-2018-05013
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 consumer,foreign
Reporter Occupation
Type of Report Initial
Report Date 01/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/01/2021
Device Catalogue NumberTSP
Device Lot Number5523900106
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/15/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/13/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 02/08/2018 Patient Sequence Number: 1
-
-