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

Model Number	VTICM5 13.2 (-8.50/2.5)
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)
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 lens rotation.Lens was explanted and replacement lens of a longer length was implanted at a later time.There are multiple medical device reports associated with this patient.This report is 1 of 2 total reports.Based on the information provided, the risk assessment for our product, and our experience, we have determined the cause or contribution to the reported issue is not indicative of a manufacturing related issue or product deficiency.No further information has been provided.If additional information is received, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
H6 - health effect clinical code: 4581 - lens rotation.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.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: 25765910
• Report Number: 2023826-2026-01208
• Device Sequence Number: 21467071
• Product Code: QCB
• UDI-Device Identifier: 00840311311996
• UDI-Public: (01)00840311311996(11)241018(17)270930
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/09/2026

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 13.2 (-8.50/2.5)
• Device Catalogue Number: VTICM5 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: 06/29/2026
• Initial Report FDA Received Date: 07/09/2026
• Date Device Manufactured: 10/18/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown