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

Model Number	VICM5_13.7 -07.50
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intraocular Pressure Increased (1937)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: investigation type 4110: lens work order search- one similar complaint event(s) within associated lots were found.The similar complaint is the fellow eye.Claim#: (b)(4).
Event or Problem Description
A facility representative reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced an excessive vault and elevated iop.Iop treatment was administered.The lens was exchanged for a shorter length lens.This report is 1 of 4 total reports.Based on the information provided, the risk assessment for our product, and our experience, we have determined the cause or contribution to the reported issue is not indicative of a manufacturing related issue or product deficiency.
Additional Manufacturer Narrative
Corrected data: b5.- a facility representative reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced excessive vault and elevated iop.Medication was prescribed.In a separate surgery the lens was exchanged with the same model and power, two sizes shorter length and the problem was resolved.The cause of the event was reported as other.Cause details provided: 'poor wtw measure'.This report is 1 of 4 total reports.Based on the information provided, the risk assessment for our product, and our experience, we have determined the cause or contribution to the reported issue is not indicative of a manufacturing related issue or product deficiency.H6-health effect- impact code: '4644' 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).

• Brand Name: EVO/EVO+ VISIAN IMPLANTABLE COLLAMER LENS
• 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 muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 23970230
• Report Number: 2023826-2026-00024
• Device Sequence Number: 7830084
• Product Code: MTA
• UDI-Device Identifier: 00840311301218
• UDI-Public: (01)00840311301218(11)231101(17)260930
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2026

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
• Device Expiration Date: 09/30/2026
• Device Model Number: VICM5_13.7 -07.50
• Device Catalogue Number: VICM5_13.7
• 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: 12/11/2025
• Supplement Date Received by Manufacturer: 03/14/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 03/14/2026
• Date Device Manufactured: 11/01/2023
• 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: INJECTOR MODEL: LIOLI-24, LOT# UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown