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

Catalog Number ATL

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

Patient Problems Bacterial Infection (1735); Corneal Ulcer (1796); Foreign Body Sensation in Eye (1869); Irritation (1941); Keratitis (1944); Pain (1994); Red Eye(s) (2038); Corneal Infiltrates (2231)

Event Date 01/25/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On 09oct2020 a johnson and johnson sales representative in canada sent an email advising an eye care provider (ecp) had a patient who experienced issues while wearing the acuvue® vita¿ brand contact lenses.On 20oct2020 additional information was provided by the ecp¿s representative.The pt was seen on (b)(6) 2020 and diagnosed with od infiltrative keratitis and od bacterial corneal ulcer.The representative reported pt symptoms of foreign body sensation, redness, pain, and soreness and initially self-treated with visine eye drops.The pt reported no change in the contact lens solution, biotrue.The pt was prescribed lotemax 1 drop q2h for 2 days, then qid until follow-up.The pt was also prescribed vigamox eye drops q2h for 2 days, then qid until follow-up.Follow-up visit 29jan2020: the record reflects the infiltrates and staining od continued; diagnosis provided was infiltrative keratitis od.The pt was advised with continue lotemax and vigamox od eye drops (no frequency noted) until follow-up visit.On (b)(6) 2020 the pt presented for follow-up and had slight infiltrates in od.The pt was advised to continue lotemax qid for 2 weeks, then bid for 1 week, then ok to resume contact lens wear.No return visit is noted.No additional information is expected.The lot number of the suspect product is not available.The suspect od contact lens was discarded.No analysis could be conducted.If any further relevant information is received, a supplemental report will be filed.

• Brand Name: ACUVUE VITA
• Type of Device: SOFT CONTACT LENS, 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 Key: 10812438
• MDR Text Key: 217643067
• Report Number: 1057985-2020-00058
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): Y
• Reporter Country Code: CA
• PMA/PMN Number: K160212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• 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: UNK-ATL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention