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

Model Number	VICM5 12.6 (-10.00)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); Halo (2227); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6- health effect- clinical code 4581: significant reduction of ica.H6 - type of investigation - lens work order search: no similar complaint type events reported for units within the same lot.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).
Event or Problem Description
A facility representative reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced excessive vault, significant reduction of iridocorneal angles and glare/haloes.In a separate visit the lens was exchanged for a shorter length lens.It was also reported that anterior chamber irrigation/evacuation of visco/fluids was performed.The problem resolved.Cause of the event was reports as unknown.

• 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: 21726808
• Report Number: 2023826-2025-00467
• Device Sequence Number: 19785515
• Product Code: MTA
• UDI-Device Identifier: 00840311300600
• UDI-Public: (01)00840311300600(11)240506(17)270430
• 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: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/28/2025

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 12.6 (-10.00)
• Device Catalogue Number: VICM5 12.6
• 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: 03/03/2025
• Initial Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/06/2024
• 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: UNK, LOT# 17711285.; FOAM TIP PLUNGER, LOT# 163328.; INJECTOR MODEL: MSI-TF, LOT# 1627949.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 28 YR
• Patient Sex: Female