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

Model Number	VICM5_12.6 (-5.5)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	02/20/2026
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 over/under correction and blurred vision.It was reported that the "patient vision is blurry when looking at distant objects without glasses." the lens was later removed.Cause of the event is unknown.Reportedly, "after removal, another examination and surgery (replacement is to be scheduled." there are multiple medical device reports associated with this patient.This report is 1 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
H6 - 4110: work order search: 1 similar complaints within associated lots were found - fellow eye.Manufacture narrative: over/under correction, blurred vision, and secondary intervention to remove the lens are identified in the labeling as a known potential adverse event following icl implantation.Claim# (b)(4).

• Brand Name: EVO/EVO+VISIAN Implantable Collamer Lens
• 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 CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016 ; +1(626)303-7902
• MDR Report Key: 50313055
• Report Number: 2023826-2026-01533
• Device Sequence Number: 18637607
• Product Code: MTA
• UDI-Device Identifier: 00840311300518
• UDI-Public: (01)00840311300518(11)250910(17)280831
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/18/2026

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 (-5.5)
• Device Catalogue Number: VICM5_12.6
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/19/2026
• Date Device Manufactured: 09/10/2025
• 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 - lot# UNK; Injector Model: MSI-PF - lot# UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female