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

Model Number	VICM5 12.6 (-6.00)
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	08/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility representative reported that an implantable collamer lens was implanted into the patient's eye.The patient experienced excessive vaulting, significant reduction of irido-corneal angles, with an addition of pi performed.The lens was explanted and the problem was resolved.The cause of the event was reported as user error and a patient related factor.
Additional Manufacturer Narrative
H6 - health effect clinical code: 4581 - significant reduction of irido-corneal angles.Manufacturer narrative: secondary surgical intervention to remove/replace/reposition the lens is identified in the labeling as a known potential adverse event following icl implantation.Claim#: (b)(4).

• Brand Name: EVO/EVO+ VISIAN Implantable Collamer Lens (ICL)
• Common Device Name: Phakic 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: 50440400
• Report Number: 2023826-2026-01618
• Device Sequence Number: 21128777
• Product Code: MTA
• UDI-Device Identifier: 00840311300525
• UDI-Public: (01)00840311300525(11)260324(17)290228
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/25/2026

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: VICM5 12.6 (-6.00)
• Device Catalogue Number: VICM5 12.6
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 08/25/2026
• Date Device Manufactured: 03/24/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Cartridge Model-SFC-45, Lot#-35057570.; Foam Tip Plunger Model-FTP, Lot#-37000048.; Injector Model-MSI-TF, Lot#-UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female