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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. - US 1-DAY ACUVUE® MOIST® FOR ASTIGMATISM LENSES, SOFT CONTACT, DAILY WEAR

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JOHNSON & JOHNSON VISION CARE, INC. - US 1-DAY ACUVUE® MOIST® FOR ASTIGMATISM LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Catalog Number 1MA
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Corneal Scar (1793); Dry Eye(s) (1814); Blurred Vision (2137); Eye Pain (4467)
Event Date 11/01/2021
Event Type  Injury  
Manufacturer Narrative
Product requested but not yet received.
 
Event Description
On 07dec2021 a reporting eye care provider (ecp) in (b)(6) called to report a patient (pt) was diagnosed with ¿severe cornea scarring due to dry eyes¿ while wearing the 1-day acuvue® moist brand contact lenses (cls) for astigmatism. The event occurred in (b)(6) 2021 and both eyes were affected. The ecp reported the pt tried lenses from multiple cls boxes and experienced discomfort, pain and blurry vision with the suspect lenses. The pt was prescribed unknown eye drops and advised to discontinue cls wear. The eyes are still ¿blurry and unwell,¿ and the pt continues to experience blurry vision while wearing spectacles. The ecp reported that the pts prescription hasn¿t changed. The ecp will contact the pt again to request the medical certificate and the name of the prescribed eye drops after the pts eyes are feeling better. On 08dec2021 the reporting ecp advised that a call will be placed to the pt on 10dec2021 to request the additional medical information. On 10dec2021 the pts reporting ecp attempted to contact the pt to obtain additional medical information. The pt is currently unavailable and is currently hospitalized for medical issues unrelated to contact lenses or both eyes. The ecp reported the pt tried 1-2 lenses from multiple cls boxes for the 1-day acuvue® moist brand contact lenses for astigmatism. The suspect lot #¿s are reported as 6026430101 and 6456460101 for the pts od. 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 6026430101 was produced under normal conditions. 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 6456460101 was produced under normal conditions. This report is for the pts od event. The report for the pts os event will be submitted in a separate report. The suspect od cls was requested for return for evaluation, but they have not yet been received. If any further relevant information is received, a supplemental report will be filed.
 
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Brand Name1-DAY ACUVUE® MOIST® FOR ASTIGMATISM
Type of DeviceLENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
JOHNSON & JOHNSON VISION CARE, INC. - US
7500 centurion parkway
jacksonville FL 32256
Manufacturer Contact
helene aguilar
7500 centurion parkway
jacksonville, FL 32256
9044433835
MDR Report Key13079166
MDR Text Key287009274
Report Number1057985-2021-00180
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeMY
PMA/PMN Number
N18033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number1MA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/01/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/02/2022
Was Device Evaluated by Manufacturer? Yes
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: 12/23/2021 Patient Sequence Number: 1
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