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

Catalog Number UNK-SOFT CONTACT LENSES

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

Patient Problem Corneal Ulcer (1796)

Event Date 03/16/2021

Event Type  Injury  

Manufacturer Narrative

Suspect product not available.

Event Description

On 15apr2021 during a routine review of the fda maude database, voluntary medwatch report # mw5100223 was discovered.A physician reported "corneal ulcer left eye from sleeping in extended wear contact lenses." the physician reported the patient (pt) was wearing an unknown acuvue® brand contact lens.The date of the event was reported as (b)(6) 2021.No contact information was provided.On 21apr2021 a letter was received from the fda with medwatch report # mw5100223.The initial report¿s contact information was provided.Multiple attempts were made to the reporting physician to obtain additional information regarding the event.No further information was received.The lot number is unknown.The suspect product is not available for return for evaluation.If any further relevant information is received, a supplemental report will be filed.

• Brand Name: UNK-SOFT CONTACT LENSES
• Type of Device: UNK-SOFT CONTACT LENSES
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. - US; 7500 centurion parkway; jacksonville FL 32256
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433647
• MDR Report Key: 11790230
• MDR Text Key: 249508877
• Report Number: 1057985-2021-00128
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2021
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other; Required Intervention