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

Model Number	VICM5 13.2 (-12.00)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	02/25/2025
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 an excessive vault and visual disturbances.The lens was replaced with a shorter length lens.
Additional Manufacturer Narrative
Secondary surgical intervention to remove/replace/reposition is identified in the labeling as a known potential adverse event(s) following icl implantation.H3: device evaluation is not required.H6: investigation type 4110: a lens work order search was performed.No additional similar complaint type events within associated lots were found.Claim: (b)(4).
Additional Manufacturer Narrative
H3: device evaluation: the lens was returned dry with debris on the lens in a microcentrifuge tube.Visual inspection found no damages to the lens.Dimensional a inspections found the lens to be within specifications.(b)(4).

• Brand Name: EVO/EVO+ VISIAN IMPLANTABLE COLLAMER LENS
• Common Device Name: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 24337087
• Report Number: 2023826-2026-00266
• Device Sequence Number: 4914415
• Product Code: MTA
• UDI-Device Identifier: 00840311300976
• UDI-Public: (01)00840311300976(11)240315(17)270228
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2026

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: VICM5 13.2 (-12.00)
• Device Catalogue Number: VICM5 13.2
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 04/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2024
• 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#: UNKNOWN; FOAM TIP PLUNGER: FTP , LOT#: UNKNOWN; INJECTOR MODEL: MIS-PF , LOT#: UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 38 YR
• Patient Sex: Female