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

Model Number	VTICM5 12.6 (-5.0/+1.0)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
A facility representative reported that an implantable collamer lens (icl) was explanted due to wrong power selected by the operator.A new lens of longer length was implanted.The cause was reported as user error.If additional information is received, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
B5 - upon further review, it has been determined that the event is not mdr reportable.Secondary surgical intervention has not occurred, and there has been no report of serious injury or malfunction.Initial mdr is not applicable.Claim # (b)(4).

• Brand Name: EVO/EVO+ VISIAN Implantable Collamer Lens
• Common Device Name: Phakic Toric Intraocular Lens
• Manufacturer (Section D): STAAR Surgical; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR Surgical; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 20603987
• Report Number: 2023826-2024-05114
• Device Sequence Number: 17978481
• Product Code: QCB
• UDI-Device Identifier: 00840311307722
• UDI-Public: (01)00840311307722(11)230715(17)260630
• Combination Product (Y/N): N
• Initial Reporter Country: IR
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/28/2026

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
• Device Expiration Date: 06/30/2026
• Device Model Number: VTICM5 12.6 (-5.0/+1.0)
• Device Catalogue Number: VTICM5 12.6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2024
• Supplement Date Received by Manufacturer: 12/10/2024; 08/09/2026
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 12/30/2024; 08/28/2026
• Date Device Manufactured: 07/15/2023
• 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 Age: 49 YR
• Patient Sex: Male