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

Model Number	VTICM5_ 12.6 (-5.00/ 1.5)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/06/2025
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 excessive vault and significant reduction of iridocorneal angles.In a separate visit the lens was exchanged for a shorter length lens and the problem was resolved.The cause of the event was reported as 'patient related factor'.
Additional Manufacturer Narrative
H6- health effect- clinical code: 4581- significant reduction of iridocorneal angles.H11- manufacturer narrative: secondary surgical intervention to remove/replace/reposition the lens is identified in the labeling as a known potential adverse event following icl implantation.(b)(4).
Additional Manufacturer Narrative
Additional information: b5.- a facility representative reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced excessive vault and significant reduction of iridocorneal angles.In a separate visit the lens was exchanged for a shorter length lens and the problem was resolved.The cause of the event was reported as unknown.D3.- date of event: "06/06/2025" should be added.Claim# (b)(4).
Additional Manufacturer Narrative
D4.Model#: "vticm5_13.2 (-5.0/ 1.5)" should be removed and "vticm5_12.6 (-5.0/ 1.5)." d4.Catalog#: vticm5_13.2" should be removed and "vticm5_12.6." 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 SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 22206996
• Report Number: 2023826-2025-00834
• Device Sequence Number: 20524283
• Product Code: QCB
• UDI-Device Identifier: 00840311308002
• UDI-Public: (01)00840311308002(11)240330(17)270228
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/13/2025

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_ 12.6 (-5.00/ 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: 06/12/2025
• Supplement Date Received by Manufacturer: 06/24/2025; 09/15/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 06/27/2025; 09/15/2025
• Date Device Manufactured: 03/30/2024
• 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#-1771292; FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK; INJECTOR MODEL-MSI-PF, LOT#-1761696
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 33 YR
• Patient Sex: Female