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

Model Number	VTICM5_12.6 (-6.0/3.5)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intraocular Pressure Increased (1937)
Date of Event	08/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6 - work order search: no additional similar complaint type events within associated lots were found.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.(b)(4).
Event or Problem Description
The reporter indicated that following an implantable collamer lens (icl) implantation procedure, the patient experienced low vault and elevated iop with pupil block.Due to low vault and elevated iop pilocarpine was used.The lens remains implanted.Final patient status is unknown.Cause of the event was reported as unknown.Additional information was requested.No further information is available at this time.This file will be re-opened if additional information is provided.
Additional Manufacturer Narrative
B5 - the reporter indicated that following an implantable collamer lens (icl) implantation procedure, the patient experienced low vault and elevated iop with pupil block.Due to low vault and elevated iop the lens was exchanged for a longer length lens.The problem was resolved.Pilocarpine was prescribed.Cause of the event was reported as unknown.
Additional Manufacturer Narrative
Upon further review, it has been determined that the event is not mdr reportable.There has been no report of serious injury or malfunction.Initial mdr is not applicable.Claim #: (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: 23069450
• Report Number: 2023826-2025-01399
• Device Sequence Number: 9809465
• Product Code: QCB
• UDI-Device Identifier: 00840311309146
• UDI-Public: (01)00840311309146(11)250310(17)280229
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 09/16/2025

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_12.6 (-6.0/3.5)
• Device Catalogue Number: VTICM5_12.6
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2025
• Supplement Date Received by Manufacturer: 10/01/2025; 10/06/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 10/06/2025; 10/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/10/2025
• 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.; FOAM TIP PLUNGER-MODEL-UNK, LOT#-UNK.; INJECTOR MODEL-MSI-PF,LOT#-UNK.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 35 YR
• Patient Sex: Female