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

Model Number	VICM5_12.6 (-10.50)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cataract (1766); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11- manufacturer narrative: cataracts is identified in the labeling as a known potential adverse event following icl implantation.H6.Health effect- clinical code (e): 4581-pigment dispersion.H6- investigation type code: 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 pigment dispersion and a cataract developed.The lens remains implanted.Reportedly, 'patient is scheduled to have cataract surgery where the icl will then be explanted'.The cause of the event is other.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Additional data: b2.Outcomes attributed to adverse events: 'other serious or important medical events' should be removed and 'required intervention to prevent permanent impairment/damage' should be added.B5.- a healthcare professional reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced pigment dispersion and a cataract developed.In a separate surgery the lens was explanted.Cataract surgery performed.Problem resolved.The cause of the event is other.H6.Health effect- impact code (f): '4627' and '4625- cataract surgery performed' should be added.Claim (b)(4).

• Brand Name: EVO/EVO + VISIAN IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia 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: 25007071
• Report Number: 2023826-2026-00723
• Device Sequence Number: 12956155
• Product Code: MTA
• UDI-Device Identifier: 00840311300617
• UDI-Public: (01)00840311300617(11)250403(17)280331
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2026

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
• Device Model Number: VICM5_12.6 (-10.50)
• Device Catalogue Number: VICM5_12.6
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2026
• Supplement Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 04/27/2026
• Supplement Report FDA Received Date: 07/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 47 YR
• Patient Sex: Female