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

Model Number	VTICM5_13.7 (-8.00/4.0)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Secondary surgical intervention to remove/replace/reposition is identified in the labeling as a known potential adverse event following icl implantation.H6: investigation type 4110: lens work order search - no similar complaint event(s) within associated lots were found.Claim: (b)(4).
Event or Problem Description
A healthcare professional reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced a lens rotation.The lens was repositioned on several occasions.The lens remains implanted.Additional information was requested.No further information is available at this time.This file will be re-opened if additional information is provided.
Additional Manufacturer Narrative
Additional information: b5: a healthcare professional reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced a lens rotation.The lens was repositioned on several occasions.The lens was explanted.Cause of the event was reported as device.Additional information was requested.No further information is available at this time.This file will be re-opened if additional information is provided claim: (b)(4).
Additional Manufacturer Narrative
Additional information: b3: date of the event: 11/22/2024.B5: a healthcare professional reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced lens rotation, repositioning was performed several times, but this did not resolve the problem.The lens was replaced with a longer length lens from a different brand & the problem was resolved.Cause of the event listed as device.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
• MDR Report Key: 22672027
• Report Number: 2023826-2025-01081
• Device Sequence Number: 7496213
• Product Code: QCB
• UDI-Device Identifier: 00840311316182
• UDI-Public: (01)00840311316182(11)240920(17)270831
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/30/2025

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_13.7 (-8.00/4.0)
• Device Catalogue Number: VTICM5_13.7
• 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: 05/26/2025
• Supplement Date Received by Manufacturer: 08/22/2025; 09/24/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 09/17/2025; 10/09/2025
• Date Device Manufactured: 09/20/2024
• 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: CARTRIDGE MODEL: SFC-45, LOT#: UNKNOWN.; CARTRIDGE MODEL: UNKNOWN , LOT#: UNKNOWN.; FOAM TIP PLUNGER: FTP, LOT#: UNKNOWN.; FOAM TIP PLUNGER: UNKNOWN , LOT#: UNKNOWN.; INJECTOR MODEL: MSI-PF , LOT#: UNKNOWN.; INJECTOR MODEL: UNKNOWN , LOT#: UNKNOWN.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 30 YR
• Patient Sex: Male