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

Model Number	VICM5_12.6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intraocular Pressure Increased (1937)
Date of Event	07/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6 - work order search: no additional similar complaint type events within associated lots were found.Iop elevation from baseline 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).
Event or Problem Description
The reporter indicated that following an implantable collamer lens (icl) implantation procedure, the patient experienced excessive vault and elevated iop.Due to excessive vault and elevated iop medication was administered.This did not resolve the problem.The lens was exchanged for a same model but shorter length lens and medication administered.The problem was resolved.Cause of the event is unknown.
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.In a separate surgery the lens was exchanged with the same model and power, shorter length and the problem was resolved.There are multiple medical device reports associated with this patient.This report is 1 of 2 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 removed.Claim# (b)(4).
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.In a separate surgery the lens was exchanged with the same model and power, shorter length.There are multiple medical device reports associated with this patient.This report is1 of 2 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 device evaluation: h3 - type of investigation code: 10- device evaluation: the lens was returned dry in a microcentrifuge tube with residue/debris on product.Visual inspection found haptic torn and residue on the lens surface.Dimensional inspection found the lens to be within specifications.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: 23839389
• Report Number: 2023826-2025-02047
• Device Sequence Number: 9816703
• Product Code: MTA
• UDI-Device Identifier: 00840311300532
• UDI-Public: (01)00840311300532(11)240407(17)270331
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Followup
• Report Date (Section B): 12/18/2025

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 Model Number: VICM5_12.6
• Device Catalogue Number: VICM5_12.6
• 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: 12/16/2025
• Supplement Date Received by Manufacturer: 03/15/2026; 03/23/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 03/15/2026; 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2024
• 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: Required Intervention
• Patient Age: 27 YR
• Patient Sex: Unknown