MAUDE Adverse Event Report: STAAR SURGICAL COMPANY EVO/EVO + VISIAN IMPLANTABLE COLLAMER LENS (ICL); PHAKIC TORIC INTRAOCULAR LENS

Model Number	VTICM5 13.2 (-8.00/ 1.0)
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	11/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation: h3 - type of investigation code: 10- device evaluation: the lens was returned dry in a microcentrifuge tube.Visual inspection found haptic broken.Dimensional inspection found the lens to be within specifications.Claim# (b)(4).
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 ac.In a separate surgery the lens was explanted and the problem was resolved.The cause of the event was reported as patient related factor.
Additional Manufacturer Narrative
H6- investigation type code: 4110- lens work order search-no similar complaint event(s) within associated lots were found.H6- health effect- clinical code: 4581- significant reduction of iridocorneal angles and shallowing of ac.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: 24288305
• Report Number: 2023826-2026-00212
• Device Sequence Number: 9408511
• Product Code: QCB
• UDI-Device Identifier: 00840311311149
• UDI-Public: (01)00840311311149(11)250828(17)280731
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2026

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 (-8.00/ 1.0)
• Device Catalogue Number: VTICM5 13.2
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2026
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 02/08/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2025
• 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 Age: 34 YR
• Patient Sex: Female