MAUDE Adverse Event Report: VISIONARY OPTICS LATITUDE; SCLERAL CONTACT LENS

Model Number	LATITUDE
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Eye / Vision Problem (4471)
Date of Event	10/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer company is proceeding with investigation complaint # (b)(4) related to this event (medwatch mw5147863).Company will file a follow up report."this report is being filed immediately after the manufacturer was granted access to webtrader".
Event or Problem Description
December 18, 2023 fda contacted manufacturer report # mw5147863 received through fda's medwatch program.Company is proceeding with an investigation related to this event.
Event or Problem Description
Initial report: december 18, 2023 fda contacted manufacturer report # mw5147863 received through fda's medwatch program.Company is proceeding with an investigation related to this event.Follow-up/closing report; (b)(6) 2024: the patient was seen for an annual visit on (b)(6) 2024.No treatment was prescribed by the doctor in relation to the incident.The patient did not report any injuries regarding this incident at the time of his annual exam.The patient's eye care provider ordered a new pair of contact lenses, different design/material.
Additional Manufacturer Narrative
Initial report: manufacturer company is proceeding with investigation (complaint # (b)(4)) related to this event (medwatch mw5147863).Company will file a follow up report."this report is being filed immediately after the manufacturer was granted access to webtrader" follow up/closing report january 16, 2024 a thorough investigation of the company's complaint records, material/material lot number, and product design was completed.No findings indicate this incident was due to material or a design defect (full investigation report documented in company complaint # (b)(4).Company completed investigation of this event, no findings to report.

• Brand Name: LATITUDE
• Common Device Name: SCLERAL CONTACT LENS
• Manufacturer (Section D): VISIONARY OPTICS; 1325 progress drive; front royal VA 22630 6425
• Manufacturer (Section G): VISIONARY OPTICS; 1325 progress drive; front royal VA 22630 6425
• Manufacturer Contact: rosemary hayes ; 1325 progress drive; front royal, VA 22630-6425 ; 5406367976
• MDR Report Key: 18540590
• Report Number: 1000123221-2023-00012
• Device Sequence Number: 20796500
• Product Code: HQD
• UDI-Device Identifier: 00865576000287
• UDI-Public: 00865576000287
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring,Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2023

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: LATITUDE
• Device Lot Number: 2936
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2023
• Supplement Date Received by Manufacturer: 12/18/2023
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 01/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2023
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 44 YR
• Patient Sex: Male