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

Model Number	VICM5_13.2(-10)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	03/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that following an implantable collamer lens (icl) implantation procedure, the patient experienced refractive surprise and corneal swelling.Due to refractive surprise and corneal swelling, the lens was explanted.On the same day in a separate surgery the lens was replaced for a same model, length but weaker power lens.Cause of the event was reported as unknown.
Additional Manufacturer Narrative
H6 - work order search: no additional similar complaint type events within associated lots were found.Refractive surprise: each lens is subjected to a 100% assessment of the power (spherical and cylinder) and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.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).
Additional Manufacturer Narrative
B5 - the reporter indicated that following an implantable collamer lens (icl) implantation procedure, the patient experienced refractive surprise.The lens was explanted.On the same day in a separate surgery the lens was replaced for a same model, length but weaker power lens.The problem was resolved.Cause of the event was reported as unknown.G3 - date received by manufacturer: 16-mar-2026 correct to 06-mar-2026 h3 - device evaluation: the lens was returned in liquid in a vial with residue/debris on the lens.Visual inspection found no visible damage to the lens but foreing material on the lens surface, specifcally, residue on the lens.Dimensional and functional inspection found the lens to be within specifications.H6 - health effect - impact code: 4625 removed from inital mdr claim #(b)(4).

• Brand Name: EVO/EVO+ VISIAN IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SUGICAL COMPANY; 1911 walker avenue; monrovia 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 24612086
• Report Number: 2023826-2026-00454
• Device Sequence Number: 18561435
• Product Code: MTA
• UDI-Device Identifier: 00840311300938
• UDI-Public: (01)00840311300938(11)241030(17)270930
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2026

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 Model Number: VICM5_13.2(-10)
• Device Catalogue Number: VICM5_13.2
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2026
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2024
• 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#-UNK; INJECTOR MODEL-UNK,LOT#-UNK; UNK-MODEL-UNK, LOT#-UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR
• Patient Sex: Male