MAUDE Adverse Event Report: BLANCHARD VISION CORP. OPTIMUM EXTRA ONEFIT MED; SCLERAL CONTACT LENS

Model Number	roflufocon D
Health Effect - Clinical Codes	Corneal Ulcer (1796); Iritis (1940); Halo (2227)
Date of Event	12/16/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient is a subject in a clinical study for the onefit med scleral lens manufactured from the optimum extra rgp material.The patient wore the lens for 45 minutes on the morning of (b)(6) 2021 after which the patient wore their daily disposable soft contact lens.Onset of haloes vision was noticed on the morning of (b)(6) 2021 and the daily disposable soft lenses were discontinued.The patient was presented at (b)(6) clinic on (b)(6) 2021 where a corneal ulcer of ~1- 1.5mm in size and mild iritis were diagnosed.The patient was treated with antibiotic eye drop and ointment.As of (b)(6) 2021 the adverse event was resolved and patient's corneal health is now fine.

• Brand Name: OPTIMUM EXTRA ONEFIT MED
• Common Device Name: SCLERAL CONTACT LENS
• Manufacturer (Section D): BLANCHARD VISION CORP.; 1552 rue king ouest, suite 200; sherbrooke, quebec J1J 2 C3; CA J1J 2C3
• Manufacturer (Section G): CONTAMAC; 806 kimball avenue; grand jct. CO 81501
• Manufacturer Contact: vimala punsammy ; 1552 rue king ouest, suite 200; sherbrooke, quebec J1J 2-C3 ; CA J1J 2C3
• MDR Report Key: 13285885
• Report Number: 9612500-2022-00001
• Device Sequence Number: 4872774
• Product Code: HQD
• UDI-Device Identifier: 00865576000201
• UDI-Public: 00865576000201
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K180616
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection,Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: roflufocon D
• Device Catalogue Number: roflufocon D
• Device Lot Number: 4205878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2021
• Initial Report FDA Received Date: 01/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 38 YR
• Patient Sex: Female