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

Model Number	VICM5_13.2(-4.5)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	03/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that following an implantable collamer lens (icl) implantation procedure, the patient experienced glares/haloes, cloudy vision, unreactive pupil, iri trophy.There was medical management.This did not resolve the problem.The lens was explanted.The problem was not resolved.Cause of the event was reported as unknown.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 information was requested.No further information is available at this time.This file will be re-opened if additional information is provided.
Additional Manufacturer Narrative
H6 - h6 - work order search: no additional similar complaint type events within associated lots were found.Non-reactive pupil , significant glare and/or halos (under night driving conditions) and secondary surgical intervention to remove/replace/reposition the lens is identified in the labeling as a known potential adverse event (or a precursor to a labeled 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: 50124372
• Report Number: 2023826-2026-01467
• Device Sequence Number: 18781639
• Product Code: MTA
• UDI-Device Identifier: 00840311300822
• UDI-Public: (01)00840311300822(11)250527(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: 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,Followup
• Report Date (Section B): 08/03/2026

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: VICM5_13.2(-4.5)
• Device Catalogue Number: VICM5_13.2
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/03/2026
• Supplement Report FDA Received Date: 08/24/2026
• Date Device Manufactured: 05/27/2025
• 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-Model-UNK, Lot#-UNK; Injector Model-UNK,Lot#-UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female