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

Model Number	VTICM5_13.2(9.50/1.5)
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	03/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A healthcare professional reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced low vault with rotation.In a separate visit the lens was explanted and on the same day but different surgery the lens was replaced for a longer length lens and the problem resolved.
Additional Manufacturer Narrative
H6 - investigation type 4110: lens work order search - no similar complaint event(s) within associated lots were found.Rotation/decentration/subluxation and 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).

• Brand Name: 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: 21878094
• Report Number: 2023826-2025-00398
• Device Sequence Number: 8742045
• Product Code: QCB
• UDI-Device Identifier: 00840311311453
• UDI-Public: (01)00840311311453(11)241008(17)270930
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/21/2025

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_13.2(9.50/1.5)
• Device Catalogue Number: VTICM5_13.2
• 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: 04/09/2025
• Initial Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2024
• 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# 1762484.; FOAM TIP PLUNGER: FTP, LOT# : 1739345.; INJECTOR MODEL: UNK, LOT # UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 29 YR
• Patient Sex: Male