MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ US UNK-SOFT CONTACT LENSES; UNK-UNK-SOFT CONTACT LENSES

Catalog Number UNK-SOFT CONTACT LENSES

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

Patient Problems Dry Eye(s) (1814); Iritis (1940)

Event Type  Injury  

Event Description

On (b)(6) 2020 a patient (pt) in (b)(6) reported a past event of iritis and dry eye (affected eye not provided).The pt reported wearing (b)(4) brand contact lens (cls) and 1-day (b)(4) brand cls.It is unknown which (b)(4) brand cls was worn at the time of the event.The pt advised the eye was healed and the pt was thinking about wearing lenses again.The pt reported trying to see another doctor.The pt reported contact in the past for events, but it is unknown if this event was reported previously by the pt.No additional medical or product information was provided.No pt contact information was provided.The date of the event is unknown.The lot numbers for the (b)(4) brand contact lens (cls) and 1-day (b)(4) brand cls were discarded by the pt.The suspect lenses were discarded.No additional investigation can be conducted.This event is being reported as a worst-case event as we were unable to verify the pts diagnosis and treatment with the treating doctor.No additional information is expected.If any further relevant information is received, a supplemental report will be filed.

• Brand Name: UNK-SOFT CONTACT LENSES
• Type of Device: UNK-UNK-SOFT CONTACT LENSES
• 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: 10076842
• MDR Text Key: 195560919
• Report Number: 1057985-2020-00033
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): Y
• Reporter Country Code: JA
• 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: 05/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK-SOFT CONTACT LENSES
• Device Lot Number: UNK-UNK-SOFT CONTACT LENSES
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/07/2020
• 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