MAUDE Adverse Event Report: STAAR Surgical Company EVO/EVO+VISIAN Implantable Collamer Lens; Phakic Toric Intraocular Lens

Model Number	VTICM5 12.6 (-10.0,3.5)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility representative reported following an implantable collamer lens (icl) implantation procedure, the patient experienced rotation with repositioning.The lens was exchanged with a longer length length lens and the problem was resolved.
Additional Manufacturer Narrative
H6- health effect clinical code 4582- lens rotation.H6- type of investigation 4110- work order search: no similar complaint event reported for units within the same lot.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 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: 50920185
• Report Number: 2023826-2026-01841
• Device Sequence Number: 5804343
• Product Code: QCB
• UDI-Device Identifier: 00840311309221
• 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: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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
• Operator of Device: Health Professional
• Device Model Number: VTICM5 12.6 (-10.0,3.5)
• Device Catalogue Number: VTICM5 12.6
• 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: 09/07/2026
• Initial Report FDA Received Date: 09/28/2026
• Date Device Manufactured: 11/02/2025
• 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 Sex: Male