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

Model Number	VICM5 12.6 -08.00
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	01/27/2026
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 over/under correction.Reportedly, 'patient was dissatisfied with the residual astigmatism.Consequently the surgeon decided to change the model from icl to ticl to correct the astigmatism'.In a separate surgery the lens was exchanged with a toric model and the problem was resolved.The cause of the event was reported as unknown.
Additional Manufacturer Narrative
H11- 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.H6.Health effect- clinical code (e): 4581- over/ under correction.H6- investigation type code (b): 4110- lens work order search-no similar complaint event(s) within associated lots were found.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 Surgical Company; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 50048107
• Report Number: 2023826-2026-01378
• Device Sequence Number: 21204939
• Product Code: MTA
• UDI-Device Identifier: 00840311300563
• UDI-Public: (01)00840311300563(11)250516(17)280430
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2026

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: VICM5 12.6 -08.00
• Device Catalogue Number: VICM5 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: 07/23/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 08/19/2026
• Date Device Manufactured: 02/12/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Cartridge Model: SFC-45: Lot# UNK; Foam Tip Plunger (FTP), Lot# UNK; Injector Model: MSI-PF, Lot# UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male