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

Model Number	VTICM5 12.6 (-4.00/2.00)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Discomfort (2330)
Date of Event	11/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6 - type of investigation: 4110 - lens work order search: no similar complaint type events reported for units within the same lot.Manufacturer narrative: 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 facility representative reported that an implantable collamer lens was implanted into the patient's eye.The patient experienced refractive surprise.The lens was explanted and replaced with another lens.It was noted "doctor and patient are happy".The cause of the event was reported as unknown.
Additional Manufacturer Narrative
Corrected data: b5 - the reporter at a later date noted the patient had significant discomfort.- this should have been included in the initial medwatch report.Claim#: (b)(4).
Additional Manufacturer Narrative
H3: device evaluation: lens was returned in a microcentrifuge tube, returned with moisture.Visual inspection found the lens optic and haptic torn, with fibers on the lens.Dimensional and functional inspection found the lens 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: 23804178
• Report Number: 2023826-2025-02019
• Device Sequence Number: 9360528
• Product Code: QCB
• UDI-Device Identifier: 00840311308262
• UDI-Public: (01)00840311308262(11)251003(17)280930
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/12/2025

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 12.6 (-4.00/2.00)
• Device Catalogue Number: VTICM5 12.6
• 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: 12/15/2025
• Supplement Date Received by Manufacturer: 11/24/2025; 02/20/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 12/22/2025; 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 37 YR
• Patient Sex: Unknown