MAUDE Adverse Event Report: STAAR SURGICAL EVO/EVO+VISIAN IMPLANTABLE COLLAMER LENS; 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	01/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A4-a6: unk h6 - type of investigation: 4110 - lens work order search: no similar complaint type events reported for units within the same lot.Manufacture narrative: secondary surgical intervention to remove/replace/reposition the lens is identified in the labeling as a known potential adverse event following icl implantation.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).
Event or Problem Description
A healthcare professional reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced refractive surprise.In a separate visit the lens was explanted and replaced with the same length lens.The problem was resolved.Cause of the event was reported as patient related factor.
Additional Manufacturer Narrative
Corrected data: a1: bv.B4: 20-mar-2025.D6b: (b)(6) 2025.
Additional Manufacturer Narrative
H3: device evaluation: the lens was returned dry with residue/debris on the lens in a microcentrifuge vial.Visual inspection found the lens optic deformed, lens haptic bent and deformed.Dimensional and functional inspections found the lens to be within specifications.Claim: (b)(4).

• Brand Name: EVO/EVO+VISIAN IMPLANTABLE COLLAMER LENS
• Common Device Name: PHAKIC TORIC 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 ; 6263037902
• MDR Report Key: 21670905
• Report Number: 2023826-2025-00430
• Device Sequence Number: 4420009
• Product Code: QCB
• UDI-Device Identifier: 00840311311385
• UDI-Public: (01)00840311311385(11)240112(17)261231
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/20/2025

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
• Operator of Device: Health Professional
• 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: 03/20/2025
• Supplement Date Received by Manufacturer: 03/20/2025; 08/18/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 06/23/2025; 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2024
• 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: N/A.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female