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

Model Number	VTICMO12.6 (-15.0/2.5)
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	02/27/2025
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(s) following icl implantation.H3: device evaluation is required but has not yet been performed.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 but did not resolve the problem.At a later date the lens was exchanged & problem was resolved.
Additional Manufacturer Narrative
Corrected data: g3 - in initial mdr is corrected to 18-dec-2025.H11- statement in previous mdr is corrected to "g3-date received by manufacturer in initial mdr is corrected to 18-dec-2025.".(b)(4).
Additional Manufacturer Narrative
Corrected data: b4 - 27-feb-2025 date should be corrected to 12-jan-2026 in initial medwatch report.G3 - 19-dec-2025 date should be corrected to 12-jan-2026 in initial medwatch report.Additional information: h3 - device evaluation: lens was returned in a microcentrifuge tube, dry, with residue/debris on the product.Visual inspection found the lens haptic stretched out.Dimensional inspection found the lens within specifications.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: 24044614
• Report Number: 2023826-2026-00021
• Device Sequence Number: 9260231
• Product Code: QCB
• UDI-Device Identifier: 00840311323487
• UDI-Public: (01)00840311323487(11)240915(17)270831
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 02/27/2025

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: VTICMO12.6 (-15.0/2.5)
• Device Catalogue Number: VTICMO12.6
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2025
• Supplement Date Received by Manufacturer: 03/05/2026; 04/13/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 03/30/2026; 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2024
• 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: UNKNOWN , LOT#: UNKNOWN; FOAM TIP PLUNGER: UNKNOWN , LOT#: UNKNOWN; INJECTOR MODEL: UNKNOWN , LOT#: UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 33 YR
• Patient Sex: Unknown