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

Model Number	VTICM5 12.6 (-10.5/2.0)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140)
Date of Event	12/12/2025
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 low vault and visual disturbances (poor near vision).The lens was exchanged for a longer length lens and the problem was resolved.Cause of the event was reported as unknown.There are multiple medical device reports associated with this patient.This report is 1 of 2 total reports.Based on the information provided, the risk assessment for our product, and our experience, we have determined the cause or contribution to the reported issue is not indicative of a manufacturing related issue or product deficiency.
Additional Manufacturer Narrative
H6 - investigation type 4110: lens work order search - no similar complaint event(s) within associated lots were found.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).
Additional Manufacturer Narrative
Corrected data: b5 - "a facility representative reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced low vault and visual disturbances (poor near vision)." corrected to "a facility representative reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced low vault and blurred vision." h6 - health effect - clinical code: 2140 corrected to 2137.Claim #: (b)(4).
Event or Problem Description
A facility representative reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced low vault and blurred vision.The lens was exchanged for a longer length lens and the problem was resolved.Cause of the event was reported as unknown.There are multiple medical device reports associated with this patient.This report is 1 of 2 total reports.Based on the information provided, the risk assessment for our product, and our experience, we have determined the cause or contribution to the reported issue is not indicative of a manufacturing related issue or product deficiency.

• 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
• MDR Report Key: 24462015
• Report Number: 2023826-2026-00318
• Device Sequence Number: 18485835
• Product Code: QCB
• UDI-Device Identifier: 00840311308392
• UDI-Public: (01)00840311308392(11)251004(17)280930
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2026

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: VTICM5 12.6 (-10.5/2.0)
• Device Catalogue Number: VTICM5 12.6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2026
• Supplement Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 04/06/2026
• Date Device Manufactured: 10/04/2025
• 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 - FTP, LOT#: UNK.; INJECTOR MODEL - MSI-PF, LOT#: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR
• Patient Sex: Male