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

Model Number	VTICM5_12.6 (-8.0/1.5)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2025
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 lens rotation.The lens was removed due to sizing and replaced with a longer length lens.
Additional Manufacturer Narrative
H6: 4110, work order search: no similar complaints within associated lots were found.Manufacturer narrative: secondary surgical intervention to remove and replace the lens are identified in the labeling as a known potential adverse event following icl implantation.Claim# (b)(4).
Additional Manufacturer Narrative
D10: injector and cartridge device included.Claim# (b)(4).
Additional Manufacturer Narrative
B5: patient experienced blurred vision.Claim# (b)(4).
Additional Manufacturer Narrative
B5: low vault with rotation was observed.Lens was exchanged and the problem was resolved.Cause of the event was a patient-related-factor.Reportedly, "lens not sized properly which rotated the lens." h6: work order search was performed but was not required.Claim# (b)(4).

• Brand Name: EVO/EVO+VISIAN IMPLANTABLE COLLAMER LENS
• Common Device Name: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 800 royal oaks dr. suite:210; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 21996025
• Report Number: 2023826-2025-00657
• Device Sequence Number: 14525014
• Product Code: QCB
• UDI-Device Identifier: 00840311308064
• UDI-Public: (01)00840311308064(11)230813(17)260731
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/01/2025

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: 07/31/2026
• Device Model Number: VTICM5_12.6 (-8.0/1.5)
• Device Catalogue Number: VTICM5_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: 04/24/2025
• Supplement Date Received by Manufacturer: 05/28/2025; 06/27/2025; 07/01/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 06/27/2025; 06/27/2025; 07/01/2025
• Date Device Manufactured: 08/13/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL: SFC-45 - LOT# UNK.; FOAM TIP PLUNGER - LOT #UNK.; INJECTOR MODEL: LIOLI-24 - LOT #UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 24 YR
• Patient Sex: Female