MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. - US ACUVUE® VITA¿; LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number ATL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Conjunctivitis (1784); Dry Eye(s) (1814); Eye Injury (1845); Keratitis (1944); Local Reaction (2035); Red Eye(s) (2038); Visual Disturbances (2140); Corneal Infiltrates (2231); Eye Pain (4467)

Event Date 08/31/2021

Event Type  Injury  

Manufacturer Narrative

Suspect product requested, not received.

Event Description

On 02sep2021 a johnson and johnson representative in (b)(4) reported a patient (pt) had redness and swelling (affected eye was not provided) while wearing acuvue® vita® brand contact lens (cls).The employee reported the pt went to the hospital and was seen by a doctor.Multiple calls were placed to the pt for additional medical and product information, but nothing additional was received.On 12sep2021 a johnson and johnson sales representative reported the pt went to the hospital again recently, the date of the visit was not provided.No additional medical information was provided.On 16sep2021 a call was placed to the pt and additional information was provided.The pt experienced os discomfort and redness while wearing the suspect cls the end of last month.The pt wore the suspect cls for 2 days and the eye were red upon cls removal.The pt went to an eye care provider (ecp) on 2nd day of cls wear and advised the os cornea was red, swollen and ¿slightly ulcerated¿.The pt was prescribed an unknown eye drop and an unknown eye gel to relieve symptoms but couldn¿t provide any additional details.The os is almost recovered, but the os still feels dry occasionally.The pt was advised to discontinue cls wear.On (b)(6) 2021 the pt provided additional information.The pt reported the 1st day of cls wear was (b)(6) 2021.The suspect os cls was a bit uncomfortable.The pt removed the os suspect lens and ¿gave it a bit of rinse¿ and inserted the cls again.The pt was able to wear the cls for 8 + hours that day.On the 2nd day of cls wear the pt advised the os was ¿really uncomfortable so the pt removed the cls in the middle of the day.The pt went to an ecp the following day for evaluation.The pt used the medication as prescribed and discontinued it a few days ago.The os had not fully recovered.The pt ¿might talk to the ecp again¿.Prescribed medication: tobramycin dexamethasone ointment os; fml drops qid os and gatafloxacin eye drops q1h os.The event date is (b)(6) 2021.On (b)(6) 2021 the pts medical reports were provided by the pt.Date of visit: (eye hospital) (b)(6) 2021.Pt complains of os redness with increased ¿secretion¿ for 1 day.The exam revealed: os corneal congestion; white turbid cornea above the nose, 3mm in size; peri-stromal infiltration of the cornea, anterior chamber depth is normal; ¿aqua cells (+)¿, transparent crystal, transparent vitreous, retinal fundus in position.Va was 0.25- uncorrected and 1.0 corrected.Iop: 10.3 mmhg.Diagnosis: os keratitis and conjunctivitis.The pt was referred for corneal disease consultation.Date of visit: (b)(6) 2021: corneal disease consultation.Pt present with complaints of os redness, pain, photophobia after 2 days of cls wear.Specialist examination: conjunctival hyperemia in the left eye, with an infiltration of about ¿2mm 1mm¿ in the cornea above the nose, mild infiltration of the peripheral cornea, transparent cornea, normal anterior chamber depth, aqua cells (+), transparent lens, transparent vitreous, retinal fundus in position, no abnormality.Confocal microscopy report: central corneal epithelial defect in left eye, with spot-like high reflectance on the edge; a large number of dendritic cells in the peripheral epithelial layer; significant turbidity of the matrix; a large number of inflammatory cell infiltration.No obvious pathogens.Diagnosis: contact lens-related keratitis in the left eye.Treatment suggestion: tobramycin eye drops once a night os.0.1%fluorometholone eye drops four times a day os.Gatifloxacin eye drops once an hour os.Follow up for a week if feel unwell.Stop wearing contact lenses.Pay attention to eye hygiene.No additional medical or product information has been received.The suspect os cls was requested for return for evaluation, but it has not 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 b00vxmz was produced under normal conditions.If any further relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

One opened contact lens case was received from the customer containing two lenses for lot # b00vxmz.Lens # 1 met company standards for base curve, center thickness and diameter.A visual inspection revealed a surface mark.Lens # 2 met company standards for base curve, center thickness and diameter.No visual attributes were revealed on the visual inspection.If any further relevant information is received, a supplemental report will be filed.

• Brand Name: ACUVUE® VITA¿
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. - US; 7500 centurion parkway; jacksonville FL 32256
• Manufacturer Contact: richard holmes ; 7500 centurion parkway; jacksonville, FL 32256 ; 9548020487
• MDR Report Key: 12592795
• MDR Text Key: 277409659
• Report Number: 1057985-2021-00156
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K160212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: ATL
• Device Lot Number: B00VXMZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Female