MAUDE Adverse Event Report: STAAR Surgical Company EVO/EVO+ VISIAN Implantable Collamer Lens (ICL); Phakic Toric Intraocular Lens

Model Number	VTICMO_13.2(-17.5/3.5)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/13/2026
Type of Reportable Event	Serious Injury

• Brand Name: EVO/EVO+ VISIAN Implantable Collamer Lens (ICL)
• Common Device Name: Phakic Toric Intraocular Lens
• Manufacturer (Section D): STAAR Surgical Company; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR Sugical Company; 1911 walker avenue; monrovia 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 50941073
• Report Number: 2023826-2026-01872
• Device Sequence Number: 21522550
• Product Code: QCB
• UDI-Device Identifier: 00840311328574
• UDI-Public: (01)00840311328574(11)250306(17)280229
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/27/2026

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: Health Professional
• Device Model Number: VTICMO_13.2(-17.5/3.5)
• Device Catalogue Number: VTICMO_13.2
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2026
• Initial Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 03/06/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female