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

Model Number	VICM5_ 13.2 (-9.50)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); Halo (2227); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/27/2025
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 an excessive vault, 'open angle' and shallow ac.Reportedly, "vaulting very high.Angle open but very shallow ac.Iop normal".In a separate surgery the lens was exchanged.It has been noted that the surgeon selected a different lens size than that initially suggested by the icl calculation software.Attempts to obtain additional information have not been successful.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
H6-health effect- clinical code: '4581- narrow angles and shallow ac' should be added.H11- manufacturer narrative: 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).
Additional Manufacturer Narrative
Corrected data: h6.Health effect- impace code (f): '4627' should be removeed and '4629' should be added.B5.- a facility representative reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced an excessive vault, significant reduction of iridocorneal angles and glares/ haloes.Reportedly, 'exchange took place friday oct 10 2025'.In a separate surgery the lens was exchanged with a shorter length and the problem was resolved.The cause of the event was reported as a patient-related factor.Claim# (b)(4).
Additional Manufacturer Narrative
Additional information: b5.- a facility representative reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced an excessive vault, significant reduction of iridocorneal angles and glares/ haloes.In a separate surgery the lens was explanted and replaced with a shorter length and the problem was resolved.The cause of the event was reported as a patient-related factor.H6-health effect- clinical code: '4581- narrow angles and shallow ac' should be removed and 'significant reduction of iridocorneal angles', 2140/ 2227 should be added.H6.- health effect - impact code (f): 4629 should be removed and 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: 23397701
• Report Number: 2023826-2025-01679
• Device Sequence Number: 9983919
• Product Code: MTA
• UDI-Device Identifier: 00840311300921
• UDI-Public: (01)00840311300921(11)250529(17)280430
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 10/27/2025

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
• Operator of Device: Health Professional
• Device Model Number: VICM5_ 13.2 (-9.50)
• 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: 10/14/2025
• Supplement Date Received by Manufacturer: 11/17/2025; 01/06/2026
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 11/19/2025; 01/06/2026
• Date Device Manufactured: 05/29/2025
• 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 Age: 43 YR
• Patient Sex: Male