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

Model Number	VICMO_12.6(-14.5)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: work order search: no additional similar complaint type events within associated lots were found.Secondary surgical intervention to remove/replace/reposition the lens is identified in the labeling as a known potential adverse event following icl implantation.Claim#: (b)(4).
Event or Problem Description
The reporter indicated that following an implantable collamer lens (icl) implantation procedure, the patient experienced glare/haloes.Due to glare/haloes, the lens was explanted.A replacement lens of a stronger power, but longer length was implanted.Cause of the event is unknown.Additional information was requested.No further information is available at this time.This file will be re-opened if additional information is provided.
Additional Manufacturer Narrative
B5 - the reporter indicated that following an implantable collamer lens (icl) implantation procedure, the patient experienced icl dislocation/subluxation and glare/haloes.Due to cl dislocation/subluxation and glare/haloes, the lens was explanted.A replacement lens of a stronger power, but longer length was implanted.Cause of the event is unknown.Significant glare and/or halos (under night driving conditions) and secondary surgical intervention to remove/replace/reposition the lens 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 INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SUGICAL COMPANY; 1911 walker avenue; monrovia 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 23811476
• Report Number: 2023826-2025-02042
• Device Sequence Number: 7685891
• Product Code: MTA
• UDI-Device Identifier: 00841542122016
• UDI-Public: (01)00841542122016(11)230420(17)250331
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2025

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
• Device Expiration Date: 03/31/2025
• Device Model Number: VICMO_12.6(-14.5)
• Device Catalogue Number: VICMO_12.6
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/20/2023
• 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-UNK, LOT#-UNK.; INJECTOR MODEL-UNK, LOT#-UNK.; UNK-MODEL-UNK, LOT#-UNK.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown