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

Model Number	VTICM5_13.2 (-9.50/1.5)
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)
Date of Event	04/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Secondary surgical intervention to remove/replace/reposition is identified in the labeling as a known potential adverse event(s) following icl implantation.H6: health effect clinical code 4581: lens tilt h6: investigation type 4110: lens work order search - no similar complaint event(s) within associated lots were found.Claim: (b)(4).
Event or Problem Description
A healthcare professional reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced a lens tilt.The lens was exchanged, implanted horizontally & the problem resolved.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.

• 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: 23551222
• Report Number: 2023826-2025-01796
• Device Sequence Number: 21163936
• Product Code: QCB
• UDI-Device Identifier: 00840311311453
• UDI-Public: (01)00840311311453(11)240220(17)270131
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/13/2025

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: VTICM5_13.2 (-9.50/1.5)
• Device Catalogue Number: VTICM5_13.2
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/20/2024
• 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: UNKNOWN, LOT#: UNKNOWN.; FOAM TIP PLUNGER: UNKNOWN, LOT#: UNKNOWN.; INJECTOR MODEL: UNKNOWN, LOT#: UNKNOWN.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 19 YR
• Patient Sex: Female