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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 Abrasion (1789); Corneal Decompensation (1790); Corneal Scar (1793); Pain (1994); Red Eye(s) (2038); Excessive Tear Production (2235)
Event Date 07/08/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). (b)(6).
 
Event Description
On 30sep2019 a call was received from an eye care provider (ecp) in the (b)(6) who reported a patient (pt) experienced eye pain and ¿scratched cornea¿ os after removing the suspect lens in (b)(6) 2019. The ecp reported the pt was wearing the 1-day acuvue® moist® for astigmatism brand contact lenses (cls). The pt is awaiting an ¿operation¿ (details not provided). The pt is currently unable to wear lenses. No additional medical information was provided. On 01oct2019 additional information was provided from the reporting ecp: the ecp received a call from the pt on (b)(6) 2019 with complaints of sore, painful os with slight reduced vision. The pt was advised to go to the hospital for evaluation. On (b)(6) 2019 the pt called the ecp and complained of ongoing symptoms. Pt again was advised to go to the hospital for evaluation. On (b)(6) 2019 the pt presented for exam. The pt was diagnosed with an os corneal abrasion superiorly with minor scarring noted. Pt also reported the os was still sore after 10 days. Pt advised to go to the hospital for evaluation. On (b)(6) 2019 the pt went to the hospital and was diagnosed with an os superior corneal epitheliopathy. Va was ¿6/4 bes¿. Management: lubrication 3-4 times daily to promote healing with hyaluronic drops. Exam: unusual vortex type epitheliopathy, atypical. Sterilized le with topical antibiotics. Some abnormal epithelial healing on the cornea which should subside with drops. Consider superficial keratectomy. No additional medical information was provided. On 04oct2019 the pt provided additional medical information: on (b)(6) 2019 the pt woke (no cls) with a red/sore/watery os. Vision slightly reduced. The pt called the ecp and an appointment was scheduled for (b)(6) 2019. On (b)(6) 2019 ecp visit: advised ¿swollen cornea¿ os. No cls wear for 2 days. On (b)(6) 2019 urgent care visit: dr advised the pt there was a ¿corneal problem¿ but didn¿t know what it was. Advised pt would hear from a specialist by 5pm, but no contact was made. On (b)(6) 2019 ecp visit: pt was advised the cornea was swollen and provided pt a letter for the eye hospital. On (b)(6) 2019 eye hospital visit: pt advised ¿unusual appearance to the cornea¿ and was explained as a ¿cut that hadn¿t healed, so the surface wasn¿t smooth. ¿ to rule out infectious cause, pt was prescribed antibiotic drops to use hourly for 24 hours during the next day, then 4x daily for 4 days. On (b)(6) 2019 eye hospital fu: no change to condition, infection was ruled out. Pt advised not to wear lenses and to use lubricants 3x daily for 6 weeks. On (b)(6) 2019 eye hospital fu: no improvement in condition, advised superficial keratectomy with amniotic membrane for 7 days. Pt on waitlist for operation. Pt reports reduced vision in os. Prognosis unknown. Additional medical information was requested. No additional medical information has been received. The suspect product was requested, but it has not yet 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 6911560101 was produced under normal conditions. 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
Manufacturer Contact
rose harrell
7500 centurion parkway
jacksonville, FL 32256
9044433364
MDR Report Key9221423
MDR Text Key176347037
Report Number1057985-2019-00106
Device Sequence Number1
Product Code LPL
Combination Product (y/n)Y
Reporter Country CodeUK
PMA/PMN Number
N18033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,health profe
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number1MA
Device Lot Number6911560101
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/14/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/06/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 10/22/2019 Patient Sequence Number: 1
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