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

Model Number	VICM5_12.6 (-8.0)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	09/04/2026
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 an over/under correction.The lens was later exchanged for a same size, different power lens and the problem was resolved.
Additional Manufacturer Narrative
H6: 4110: a lens work order search has been performed: 1 similar complaint was found: 749095 manufacture narrative: over/under correction and secondary surgical intervention to remove and replace the lens are 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 Intraocular Lens
• Manufacturer (Section D): STAAR Surgical Company; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR Sugical Company; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016 ; +1(626)303-7902
• MDR Report Key: 50849607
• Report Number: 2023826-2026-01777
• Device Sequence Number: 9497504
• Product Code: MTA
• UDI-Device Identifier: 00840311300563
• UDI-Public: (01)00840311300563(11)251118(17)281031
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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: VICM5_12.6 (-8.0)
• Device Catalogue Number: VICM5_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: 09/22/2026
• Date Device Manufactured: 11/18/2025
• 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 - Lot# UNK; Foam Tip Plunger - Lot# UNK; Injector Model: MSI-PF - Lot# UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female