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

Model Number	VTICM5 13.2 (-13.0/1.5)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pupillary Block (2026); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6 - work order search: no additional similar complaint type events within associated lots were found.Pupillary block, iop elevation from baseline and 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 healthcare professional reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced pupil block with elevated iop, pigment dispersion and unreactive (fixed) pupil.Due to pupil block with elevated iop, pigment dispersion and unreactive (fixed) pupil, surgical pi was performed.On a separate day the lens was explanted.Cause of the event was reported as device.
Additional Manufacturer Narrative
B5 - a healthcare professional reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced pupil block with elevated iop, pigment dispersion and unreactive (fixed) pupil.Due to pupil block with elevated iop, pigment dispersion and unreactive (fixed) pupil, surgical pi was performed.On same day the lens was explanted.This did not resolve the problem.The cause of the event was reported as device.G4 - 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.H6 - health effect - clinical code (e): 4581 pigment dispersion.Claim # (b)(4).
Additional Manufacturer Narrative
B5 - a healthcare professional reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced pupil block with elevated iop, pigment dispersion and unreactive (fixed) pupil.Due to pupil block with elevated iop, pigment dispersion and unreactive (fixed) pupil, surgical pi was performed.On same day the lens was explanted.This did not resolve the problem.On a separate day, the lens was replaced with a different model but same length lens.This resolved the problem.Cause of the event was reported as "patient related factor".

• Brand Name: EVO/EVO+ VISIAN IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC TORIC 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: 22403524
• Report Number: 2023826-2025-00947
• Device Sequence Number: 8257285
• Product Code: QCB
• UDI-Device Identifier: 00840311311521
• UDI-Public: (01)00840311311521(11)240825(17)270731
• Combination Product (Y/N): Y
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/04/2025

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: VTICM5 13.2 (-13.0/1.5)
• Device Catalogue Number: VTICM5 13.2
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2025
• Supplement Date Received by Manufacturer: 09/13/2025; 12/04/2025
• Initial Report FDA Received Date: 07/04/2025
• Supplement Report FDA Received Date: 09/17/2025; 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2024
• 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: 27 YR
• Patient Sex: Female