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

Model Number	VICM5 13.2 (-07.00)
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	10/03/2025
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 over/under correction.The lens exchanged for a same length lens and the problem was resolved.Cause of the event was use error," surgeon used the wrong praop datas for calculation.New calculation was made, and a new lens was ordered.Patient is happy.".
Additional Manufacturer Narrative
H6 - health effect clinical code: 4581 - over/under correction.Manufacture narrative: secondary surgical intervention to remove/replace/reposition the lens and over/under correction 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 SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 23468338
• Report Number: 2023826-2025-01717
• Device Sequence Number: 8974843
• Product Code: MTA
• UDI-Device Identifier: 00840311300877
• UDI-Public: (01)00840311300877(11)241117(17)271031
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 11/04/2025

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: VICM5 13.2 (-07.00)
• Device Catalogue Number: VICM5 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: 10/03/2025
• Initial Report FDA Received Date: 11/04/2025
• Date Device Manufactured: 11/17/2024
• 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: FTP, LOT# UNK.; INJECTOR MODEL: MSI-PF, LOT # UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male