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

Model Number	VTICM5 13.2 (-13.5/ 1.5)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intraocular Pressure Increased (1937)
Date of Event	08/23/2026
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 elevated iop.Medication was prescribed.In a separate surgery the lens was explanted.The cause of the event was reported as device/user error/ unknown.Cause details provided: 'we think about wtw'.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
H6- investigation type code: 4110- lens work order search-no similar complaint event(s) within associated lots were found.H11- manufacturer narrative: iop elevation from baseline and secondary surgical intervention to remove/replace/reposition the len 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 Toric 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: 50554776
• Report Number: 2023826-2026-01666
• Device Sequence Number: 16114919
• Product Code: QCB
• UDI-Device Identifier: 00840311311538
• Combination Product (Y/N): N
• Initial Reporter Country: IZ
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/01/2026

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: VTICM5 13.2 (-13.5/ 1.5)
• Device Catalogue Number: VTICM5 13.2
• 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: 08/25/2026
• Initial Report FDA Received Date: 09/02/2026
• Date Device Manufactured: 11/01/2025
• 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: Female