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

Model Number	VICMO 13.2 (-15.50)
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	12/20/2025
Type of Reportable Event	Serious Injury
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- ' angle closure, significant reduction of shallowing of the ac and over/under correction.' h6: health impact code: 4625 - additional surgery: surgical pi was performed.H11- manufacturer narrative: iop elevation from baseline, over/under correction is identified in the labeling as a known potential adverse event following icl implantation.Claim# (b)(4).
Event or Problem Description
A facility representative reported during an implantable collamer lens (icl) implantation procedure, the lens tore while loading and during the injection/ delivery into the eye.There was patient contact but no patient injury.Reportedly, "during lens implantation, the haptic feedback was cut and four days later an increase in intraocular pressure and increase in the vault occurred".The patient experienced and excessive vault, elevated iop with angle closure, significant reduction of shallowing of the ac and over/under correction.Medication was prescribed.Surgical pi was performed.The lens remains implanted.Planned replacement.The cause of the event was reported as a patient related factor.
Additional Manufacturer Narrative
Additional information: b5.A facility representative reported during an implantable collamer lens (icl) implantation procedure, the lens tore while loading and during the injection/ delivery into the eye.There was patient contact but no patient injury.Reportedly, "during lens implantation, the haptic feedback was cut and four days later an increase in intraocular pressure and increase in the vault occurred".The patient experienced and excessive vault, elevated iop with angle closure, significant reduction of shallowing of the ac and over/under correction.Medication was prescribed.Surgical pi was performed.In a separate surgery the lens was explanted and replaced with a lens of the same parameters and the problem was resolved.Reportedly, 'the other lens was implanted, and the patient's condition is now good, and everything is fine.' the cause of the event was reported as a patient related factor.H6.Health effect- impact code (f): 4627' should be added.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: 24120609
• Report Number: 2023826-2026-00086
• Device Sequence Number: 5941759
• Product Code: MTA
• UDI-Device Identifier: 00840311302529
• UDI-Public: (01)00840311302529(11)250605(17)280531
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 01/20/2026

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: VICMO 13.2 (-15.50)
• Device Catalogue Number: VICMO 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: 12/29/2025
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 02/23/2026
• Date Device Manufactured: 06/05/2025
• 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: 25 YR
• Patient Sex: Female