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

Model Number	VTICM5 13.2 (-10.5/3.0)
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	03/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6 - clinical code 4581: significant reduction of irido-corneal angles.(b)(4).
Event or Problem Description
A healthcare professional reported that following an implantable collamer lens (icl) implantation procedure the patient experienced excessive vault and significant reduction of irido-corneal angles.At a later date the lens was exchanged for a shorter length lens and the problem was resolved.Cause of the event was reported as patient related factor.
Additional Manufacturer Narrative
Corrected data: b3 - date of event: 04-mar-2025.Claim#: (b)(4).
Event or Problem Description
A healthcare professional reported that following an implantable collamer lens (icl) implantation procedure the patient experienced excessive vault and significant reduction of irido-corneal angles.At a later date the lens was exchanged for a different model lens of a shorter length.The problem was resolved.Cause of the event was reported as unknown.
Additional Manufacturer Narrative
Corrected data: a2 - date of birth: (b)(6) 1985.B5 - describe event or problem: a healthcare professional reported that following an implantable collamer lens (icl) implantation procedure the patient experienced excessive vault and significant reduction of irido-corneal angles.At a later date the lens was exchanged for a different model lens of a shorter length.The problem was resolved.Cause of the event was reported as unknown.D4 - model #: vticm5 13.2 (-10.5/3.0).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 ave; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 21997453
• Report Number: 2023826-2025-00666
• Device Sequence Number: 18494812
• Product Code: QCB
• UDI-Device Identifier: 00840311312313
• UDI-Public: (01)00840311312313(11)240108(17)261231
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/09/2025

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 (-10.5/3.0)
• 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: 04/16/2025
• Supplement Date Received by Manufacturer: 06/27/2025; 07/15/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 07/10/2025; 07/15/2025
• Date Device Manufactured: 01/08/2024
• 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, LOT UNK; INJECTOR MODEL: MSI-PF, LOT # UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR
• Patient Sex: Male