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

Model Number	VICMO 13.2 (-14.50)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	03/29/2025
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 refractive surprise.At a later date the lens was exchanged for a lens of a different power which resolved the issue.Cause of the event was reported as unknown.
Additional Manufacturer Narrative
H6, investigation type code: 4110, lens work order search-no similar complaint event(s) within associated lots were found.Claim (b)(4).
Additional Manufacturer Narrative
H3: device evaluation - lens was returned in microcentrifuge tube dry.Visual inspection found no visible damage.Dimensional and functional inspection found the lens to be within specification.Claim# (b)(4).

• 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 ave; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 21997462
• Report Number: 2023826-2025-00664
• Device Sequence Number: 13114733
• Product Code: MTA
• UDI-Device Identifier: 00840311302505
• UDI-Public: (01)00840311302505(11)240304(17)270228
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• 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: VICMO 13.2 (-14.50)
• Device Catalogue Number: VICMO 13.2
• 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: 04/14/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2024
• 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 Sex: Female