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

Model Number	VTICMO 12.6 (-17.00/ 4.0)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility representative reported that following an implantable collamer lens (icl) implantation replacement procedure as a replacement lens, the patient experienced excessive vault post op.Yag was performed.The lens remains implanted.Reportedly, "during the last check-up the bcva was 0.7 for both eyes.Measurements with the cso sirius indicated a vaulting of 0.88 and 0.89 mm in od and os respectively.For safety's sake i have performed a yag laser iridotomy.The patient is quite happy." if additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
H6: investigation type code: 4110: lens work order search-no similar complaint event(s) within associated lots were found.H6: health effect - impact code: 4625 - yag laser iridotomy was performed.H11: manufacturer narrative: additional yag iridotomy is identified in the labeling as a known potential adverse event following icl implantation.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: 23791692
• Report Number: 2023826-2025-01997
• Device Sequence Number: 10470099
• Product Code: QCB
• UDI-Device Identifier: 00840311324606
• UDI-Public: (01)00840311324606(11)230918(17)260831
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• 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 Expiration Date: 08/31/2026
• Device Model Number: VTICMO 12.6 (-17.00/ 4.0)
• Device Catalogue Number: VTICMO 12.6
• Device Lot Number: N/A
• 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: 12/08/2025
• Initial Report FDA Received Date: 12/12/2025
• Date Device Manufactured: 09/18/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female