MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ US ACUVUE 2; LENSES, SOFT CONTACT, EXTENDED WEAR

Catalog Number AV2

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

Patient Problems Bacterial Infection (1735); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter¿s phone number: (b)(6).

Event Description

On (b)(6) 2020, a patient (pt) in (b)(6) reported ou pain and a diagnosis of ou bacterial infection 6 years ago (2014) while wearing acuvue® 2® brand contact lenses.The eye care provider (ecp) prescribed an unknown eye drop, every 8 hours, and an unknown cream, nightly.The pt was not able to recall the exact duration of treatment, but believes it was for 15-20 days.The ecp contact information is not available.The pt reported sleeping in contact lenses and was advised by the ecp that the bacterial infection was due to poor contact lens hygiene.After the treatment concluded, the pt was able to successfully return to contact lens wear.No further information was provided.No additional medical information is expected to be received.This event is being filed as a worst-case event as we were unable to verify the pts diagnosis and treatment.This report is for the pts od event.The report for the pts os event will be filed in a separate report.The suspect lot number is unknown.The suspect contact lenses were discarded.No additional investigation can be conducted.If any further relevant information is received, a supplemental report will be filed.

• Brand Name: ACUVUE 2
• Type of Device: LENSES, SOFT CONTACT, EXTENDED 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: 10860405
• MDR Text Key: 216967719
• Report Number: 1057985-2020-00062
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): Y
• Reporter Country Code: BR
• PMA/PMN Number: N18033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: AV2
• Device Lot Number: UNK-AV2
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/27/2020
• 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): Required Intervention; Disability