MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND 1-DAY ACUVUE TRUEYE (NARA A); LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number 1D4

Device Problem No Apparent Adverse Event (3189)

Patient Problems Eye Injury (1845); Foreign Body Sensation in Eye (1869); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2017 a johnson and johnson employee reported a patient (pt) used an acuvue brand contact lens ¿causing it to injure the pts eye¿.The employee provided the pts contact information so additional information could be obtained as he/she didn¿t have complaint details.On 16aug2017 the pt called and provided the additional information as follows: pt reported in (b)(6) 2017 he/she ¿felt a pinch in his/her eye¿ when the suspect lens was removed from the left eye.Pt reported he/she was unable to wear lenses for five to seven days after the event due to discomfort.Pt stated ¿it felt like a lash in his/her eye¿.The pt went to an eye care provider (ecp) and was diagnosed with ¿os corneal lesion¿ and was prescribed epitegel.Pt thinks it was prescribed every 4 hours for 15 days, then it was reduced.Pt reported he/she tried to wear lenses again, but was unable to put a lens in the os.The pt consulted a corneal specialist and was advised he/she had a corneal scar on the os.Pt was then prescribed corticosteroids and elogel lubricating drops.Pt reported the lesion/scar is on the 1st upper quadrant, closer to the central region, inferior part of quadrant.On (b)(6) 2017 pt reported a visit to a third ecp who prescribed epitegel lubricating drops four times daily and alrex corticosteroid for six days and hyabek (pt did not provide how many times daily they were prescribed).Pt reported he/she has a follow-up visit, but refused to provide additional information.Pt also refused to provide the contact information for the 3 ecp¿s the pt saw for the reported event.Pt reported he/she is wearing glasses and has not returned to contact lens wear.Pt reported using good handwashing technique and doesn¿t know why the event occurred.The pt did not have the suspect lot number information at the time of the call, but reported he/she would provide the information by email.The suspect lens was discarded.No additional medical information was obtained.On 18aug2017 an email was received from the pt with the lot # from the suspect lens package; the product was noted as 1-day acuvue trueye brand contact lens.Additional medical information was requested, but no additional medical information has been received.A lot history review was performed for lot number 5821270101 which 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 3623430766 was produced under normal conditions.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.

• Brand Name: 1-DAY ACUVUE TRUEYE (NARA A)
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND; one technological park plassey; limerick ; EI
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 6853092
• MDR Text Key: 85449985
• Report Number: 9617710-2017-05041
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K073485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/01/2021
• Device Catalogue Number: 1D4
• Device Lot Number: 5821270101
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention