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

Model Number	VTICM5 12.6 (-9.50/ 1.00)
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	04/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility representative reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced an excessive vault and over/ under correction.In a separate surgery the lens was exchanged with a shorter/spherical lens and the problem was resolved.Reportedly, 'the astigmatism was slightly overcorrected, so the lens was exchanged for a spherical lens'.The cause of the event was report as unknown.There are multiple medical device reports associated with this patient.This report is 2 of 2 total reports.Based on the information provided, the risk assessment for our product, and our experience, we have determined the cause or contribution to the reported issue is not indicative of a manufacturing related issue or product deficiency.
Additional Manufacturer Narrative
H11- manufacturer narrative: over/ under correction and secondary surgical intervention to remove/replace/reposition the lens is identified in the labeling as a known potential adverse event following icl implantation.H6.Health effect- clinical code (e): 4581- over/ under correction.Claim# (b)(4).

• 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 91016
• Manufacturer (Section G): STAAR Surgical Company; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 50437788
• Report Number: 2023826-2026-01510
• Device Sequence Number: 12988942
• Product Code: QCB
• UDI-Device Identifier: 00840311307814
• UDI-Public: (01)00840311307814(11)250428(17)280331
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,User Facility,Company Representative,Distributor
• 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
• Device Model Number: VTICM5 12.6 (-9.50/ 1.00)
• Device Catalogue Number: VTICM5 12.6
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2026
• Initial Report FDA Received Date: 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/28/2025
• 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