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

Model Number	VICM5_13.2 (-7.50)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/03/2026
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 excessive vault, elevated iop, significant reduction of iridocorneal angles and significant shallowing of the ac.Medication was prescribed.Reportedly, 'iop was reduced in office same day and never elevated again' and 'pupil is fully reactive'.The lens remains implanted.The cause of the event was reported as unknown.Attempts to obtain additional information have not been successful.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
H11- manufacturer narrative: iop elevation from baseline is identified in the labeling as a known potential adverse event following icl implantation.H6.Health effect- clinical code (e): 4581- 'significant reduction of iridocorneal angles'; 'shallowing of the ac'; 'reactive pupil'.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: 50330526
• Report Number: 2023826-2026-01554
• Device Sequence Number: 14823433
• Product Code: MTA
• UDI-Device Identifier: 00840311300884
• UDI-Public: (01)00840311300884(11)250815(17)280731
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/19/2026

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_13.2 (-7.50)
• Device Catalogue Number: VICM5_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: Not provided
• Initial Report FDA Received Date: 08/19/2026
• Date Device Manufactured: 08/15/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female