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

Model Number	VTICM5 13.2 (-11.50/3.50)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intraocular Pressure Increased (1937)
Date of Event	09/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6 - type of investigation: 4110 - lens work order search: no similar complaint type events reported for units within the same lot.Manufacturer narrative: elevated intraocular pressure, 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
A facility representative reported that an implantable collamer lens was implanted into the patient's eye.The patient experienced elevated intraocular pressure, angle closure, with shallow ac.The lens was exchanged with a shorter length lens and the problem was resolved.

• Brand Name: EVO/EVO+VISIAN IMPLANTABLE COLLAMER LENS
• Common Device Name: PHAKIC TORIC 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: 23330778
• Report Number: 2023826-2025-01618
• Device Sequence Number: 9845438
• Product Code: QCB
• UDI-Device Identifier: 00840311312610
• UDI-Public: (01)00840311312610(11)240415(17)270331
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• 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 Model Number: VTICM5 13.2 (-11.50/3.50)
• 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: 10/17/2025
• Initial Report FDA Received Date: 10/17/2025
• Date Device Manufactured: 04/15/2024
• 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-SFC-45, LOT#-UNK.; FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 22 YR
• Patient Sex: Female