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

Model Number	VICM5 13.2 (-8.5)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	05/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6 - work order search: no additional similar complaint type events within associated lots were found.Refractive suprirse - 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).
Event or Problem Description
Pb a healthcare professional reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced refractive surprise.Due to refractive surprise, the lens was exchanged for a same model and length lens.The problem was resolved.Cause of the event was reported as unknown.
Additional Manufacturer Narrative
H3 - device evaluation: the lens was returned dry in a microcentrifuge vial.Visual inspection found no visible damage to the lens but noted foreign material on the lens surface, specifically, fibers.Dimensional inspection found the lens to be within specifications.Functional inspection found that the returned lens did not meet original values measured at the time of manufacturing.Claim # (b)(4).
Additional Manufacturer Narrative
B5 - a healthcare professional reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced refractive surprise.Due to refractive surprise, the lens was exchanged for a same model, length but different power lens.The problem was resolved.Cause of the event was reported as unknown.G4 - 4.Premarket identification pma/510(k): p030016 combination product corrected to no in initial mdr.H6 - type of investigation 3331 - device history record (dhr) review: based on the results of the investigation, all released devices from the associated work order(s), including the suspected device, have been manufactured within established process parameters and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.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: 22294223
• Report Number: 2023826-2025-00864
• Device Sequence Number: 8309913
• Product Code: MTA
• UDI-Device Identifier: 00840311300907
• UDI-Public: (01)00840311300907(11)240924(17)270831
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/19/2025

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
• Device Model Number: VICM5 13.2 (-8.5)
• 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: 06/19/2025
• Supplement Date Received by Manufacturer: 07/30/2025; 10/03/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 08/27/2025; 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2024
• 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-MODEL-UNK, LOT#-UNK.; INJECTOR MODEL-MSI-PF,LOT#-UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 21 YR
• Patient Sex: Female