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

Model Number	VICM5 13.2 (-9.50)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	03/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: manufacture narrative: secondary surgical intervention to remove/replace/reposition the lens is identified in the labeling as a known potential adverse event following icl implantation.H11: manufacture narrative: refractive surprise each lens is subjected to a 100% assessment of the power (spherical and cylinder) and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.H3 - device evaluation is not required.Claim #: (b)(4).
Event or Problem Description
A facility representative reported that following an implantable collamer lens (icl) implantation procedure the patient experienced excessive vault, significant reduction of iridocorneal angles, ac shallowing, refractive surprise.The doctor considered lasik but that was not the right option due to the adverse events.The lens exchanged for a shorter length lens and different power and the problem resolved.The cause of event was reported as patient related factor.
Additional Manufacturer Narrative
Claim# (b)(4) was found to be a duplicate of claim# (b)(4).Mdr (b)(4) should be claim# (b)(4).H3 - device evaluation: the lens was returned in liquid in a vial.Visual inspection found no visible damage to the lens.Dimensional and functional inspection found the lens to be within specifications claim # (b)(4).
Additional Manufacturer Narrative
H6: investigation type 4110: lens work order search - no similar complaint event(s) within associated lots were found.Claim # (b)(4).

• Brand Name: EVO/EVO+VISIAN IMPLANTABLE COLLAMER LENS
• Common Device Name: PHAKIC 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 muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 22822138
• Report Number: 2023826-2025-01168
• Device Sequence Number: 8776901
• Product Code: MTA
• UDI-Device Identifier: 00840311300921
• UDI-Public: (01)00840311300921(11)240422(17)270331
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/15/2025

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: VICM5 13.2 (-9.50)
• Device Catalogue Number: VICM5 13.2
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2025
• Supplement Date Received by Manufacturer: 08/18/2025; 09/19/2025
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 09/16/2025; 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female