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

Model Number	VTICM5_13.2(-6.0/1.5)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	11/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6 - work order search: no additional similar complaint type events within associated lots were found.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
The reporter indicated that following an implantable collamer lens (icl) implantation procedure, the patient experienced low vault and refractive surprise.Due to low vault and refractive surprise, the lens was exchanged for a longer length lens.The problem was resolved.Cause of the event was reported as unknown.
Additional Manufacturer Narrative
B5 - the reporter indicated that following an implantable collamer lens (icl) implantation procedure, the patient experienced low vault and refractive surprise.Due to low vault and refractive surprise, the lens was exchanged for a same model, longer length but weaker power lens.The problem was resolved.Cause of the event was reported as unknown.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.Claim # (b)(4).
Additional Manufacturer Narrative
H3 - device evaluation: the lens was returned dry in a microcentrifuge tube with residue/debris on the lens.Visual inspection found the lens optic deformed and scratched and the haptic broken, bent, deformed and scratched.Dimensional inspection found the lens to be within specifications.Functional inspection found that the lens did not meet original values measured at the time of manufacturing.Claim # (b)(4).
Additional Manufacturer Narrative
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.(b)(4).

• 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: 23659366
• Report Number: 2023826-2025-01900
• Device Sequence Number: 10124107
• Product Code: QCB
• UDI-Device Identifier: 00840311311385
• UDI-Public: (01)00840311311385(11)250317(17)280229
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 11/26/2025

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(-6.0/1.5)
• Device Catalogue Number: VTICM5_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: 11/25/2025
• Supplement Date Received by Manufacturer: 02/27/2026; 03/31/2026; 07/07/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 02/27/2026; 04/29/2026; 07/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2025
• 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; CARTRIDGE MODEL-SFC-45, LOT#-UNK.; FOAM TIP PLUNGER-MODEL-UNK, LOT#-UNK; FOAM TIP PLUNGER-MODEL-UNK, LOT#-UNK.; INJECTOR MODEL-MSI-PF,LOT#-UNK; INJECTOR MODEL-MSI-PF,LOT#-UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR
• Patient Sex: Male