MAUDE Adverse Event Report: STAAR Surgical Company EVO/EVO+ VISIAN Implantable Collamer Lens; PHAKIC INTRAOCULAR LENS

Model Number	VICMO 13.2 (-15.00)
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	08/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility representative reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced excessive vault with significant reduction of iridocorneal angles and significant shallowing of the ac, cloudy vision and refractive surprise.Lens was exchanged for a shorter length lens and problem was resolved.Cause of the event was reported as unknown.
Additional Manufacturer Narrative
H6: investigation type 4110: a lens work order search was performed.No additional similar complaint type events within associated lots were found.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.Each lens is subjected to a 100% assessment of the power (spherical and cylinder) and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.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: 50937370
• Report Number: 2023826-2026-01868
• Device Sequence Number: 16137256
• Product Code: MTA
• UDI-Device Identifier: 00840311302512
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• 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): 09/29/2026

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: VICMO 13.2 (-15.00)
• Device Catalogue Number: VICMO 13.2
• 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: 09/29/2026
• Initial Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 05/10/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Cartridge Model: SFC-45, Cartridge Lot: 1835370.; FTP, FTP Lot: 1829671.; Injector Model: MSI-PF, Injector Lot.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female