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

Model Number	VTICM5_13.2 (-13.00/3.5)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A healthcare professional reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced an excessive vault with a significant reduction of ica & shallowing of the ac.The lens was exchanged with a shorter length lens & the problem was resolved.Cause of the event was reported as unknown.
Additional Manufacturer Narrative
Secondary surgical intervention to remove/replace/reposition is identified in the labeling as a known potential adverse event following icl implantation.H6: health effect clinical code 4581: significant reduction of ica ; shallowing of the ac claim: (b)(4).
Additional Manufacturer Narrative
B5: a healthcare professional reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced an excessive vault, significant reduction of ica & shallowing of the ac.The lens was exchanged for a shorter length lens, with a surgical pi & the problem was resolved.H6 health effect: 4625.(b)(4).

• Brand Name: EVO/EVO+ VISIAN IMPLANTABLE COLLAMER LENS
• Common Device Name: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 23331338
• Report Number: 2023826-2025-01565
• Device Sequence Number: 18187342
• Product Code: QCB
• UDI-Device Identifier: 00840311312641
• UDI-Public: (01)00840311312641(11)221005(17)250930
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2025

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 Expiration Date: 09/30/2025
• Device Model Number: VTICM5_13.2 (-13.00/3.5)
• Device Catalogue Number: VTICM5_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: 09/24/2025
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 01/07/2026
• Date Device Manufactured: 10/05/2022
• 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#: UNKNOWN.; FOAM TIP PLUNGER: FTP , LOT#: UNKNOWN.; INJECTOR MODEL: MSI-PF , LOT#: UNKNOWN.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 24 YR
• Patient Sex: Female