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

Model Number	VICM5_12.1 (-10.0)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intraocular Pressure Increased (1937)
Date of Event	02/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility representative reported that following a replacement implantable collamer lens (icl) implantation procedure, the patient experienced elevated iop.Reportedly, "tapping the anterior chamber at the slit lamp while the patient was in recovery (same day of surgery) is a treatment chosen by the surgeon to evacuate some retained viscoelastic and lower the iop to a normalized level.This is the surgeon's preferred management.".
Additional Manufacturer Narrative
4110: a lens work order search has been performed: no similar complaints within associated lots were found.Manufacture narrative: elevated iop 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: 50489005
• Report Number: 2023826-2026-01604
• Device Sequence Number: 10646649
• Product Code: MTA
• UDI-Device Identifier: 00840311300273
• UDI-Public: (01)00840311300273(11)250602(17)280531
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

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_12.1 (-10.0)
• Device Catalogue Number: VICM5_12.1
• 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: 08/18/2026
• Initial Report FDA Received Date: 08/28/2026
• Date Device Manufactured: 06/02/2025
• 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: UNK.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Female