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

Model Number	VTICMO 12.1 (-15.00/ 1.50)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	01/30/2025
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 blurred vision and lens rotation/ lens repositioning.The lens remains implanted.Reportedly, "the lens exchange surgery is expected to take place on (b)(6) 2025." the cause of the event was reported as other.Attempts to obtain additional information have not been successful.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
H11- 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.H6- investigation type code: 4110- lens work order search- one similar complaint event(s) within associated lots were found.Claim# (b)(4).
Additional Manufacturer Narrative
Additional information: b5.- in a separate surgery the lens was exchanged with a longer length.D6b.- '01-29-2026' should be added.H6.- health effect- impact code (f): '4629' should be added.Claim# (b)(4).
Additional Manufacturer Narrative
Additional information: b5.-a facility representative reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced blurred vision and lens rotation/ lens repositioning.In a separate surgery the lens was exchanged with a longer length and the problem was resolved.Reportedly, 'the patient has already been examined and the problem has been resolved; the lens correctly positioned without rotation and with a vault of 650'.The cause of the event was reported as other.Device evaluation: h3 - type of investigation code: 10- device evaluation: the lens was returned dry in a microcentrifuge tube with liquid and residue/debris on product.Visual inspection found haptic bent.Dimensional inspection found the lens to be within specifications.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 SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 23823044
• Report Number: 2023826-2025-02027
• Device Sequence Number: 18643617
• Product Code: QCB
• UDI-Device Identifier: 00840311318445
• UDI-Public: (01)00840311318445(11)230121(17)251231
• 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: 2023
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/16/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2025
• Device Model Number: VTICMO 12.1 (-15.00/ 1.50)
• Device Catalogue Number: VTICMO 12.1
• 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: 11/21/2025
• Supplement Date Received by Manufacturer: 02/11/2026; 03/31/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 02/24/2026; 04/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2023
• 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: INJECTOR MODEL: MSI-PF, LOT# UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 30 YR
• Patient Sex: Female