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

Model Number	VICM5_12.1 (-07.00)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Halo (2227); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A healthcare professional reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced haloes.The lens was explanted.There are multiple medical device reports associated with this patient.This report is 1 of 2 total reports.Based on the information provided, the risk assessment for our product, and our experience, we have determined the cause or contribution to the reported issue is not indicative of a manufacturing related issue or product deficiency.Additional information was requested.No further information is available at this time.This file will be re-opened if additional information is provided.
Additional Manufacturer Narrative
Significant glare and/or halos & secondary surgical intervention to remove/replace/reposition the lens are identified in the labeling as a known potential adverse event following icl implantation.H6: investigation type 4110: lens work order search - no similar complaint event(s) within associated lots were found.Claim: (b)(4).
Additional Manufacturer Narrative
Additional info: a2: age: 34 years; d.O.B.: (b)(6) 1991.A3: date of event: (b)(6) 2025.B5: a healthcare professional reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced blurred vision, glares/haloes and over/under correction.The lens was explanted, and the problems were resolved.Cause of the event was reported as patient related factor.There are multiple medical device reports associated with this patient.This report is 1 of 2 total reports.Based on the information provided, the risk assessment for our product, and our experience, we have determined the cause or contribution to the reported issue is not indicative of a manufacturing related issue or product deficiency.Additional information was requested.No further information is available at this time.This file will be re-opened if additional information is provided.H6: health effect clinical code 4581: over/under correction.Claim: (b)(4).

• Brand Name: EVO/EVO+ VISIAN IMPLANTABLE COLLAMER LENS
• Common Device Name: PHAKIC 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: 22847123
• Report Number: 2023826-2025-01202
• Device Sequence Number: 8421501
• Product Code: MTA
• UDI-Device Identifier: 00840311300211
• UDI-Public: (01)00840311300211(11)240727(17)270630
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2025

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_12.1 (-07.00)
• Device Catalogue Number: VICM5_12.1
• 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: 07/24/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 10/03/2025
• Date Device Manufactured: 07/27/2024
• 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: LIOLI-24 , LOT#: UNKNOWN; INJECTOR MODEL: UNKNOWN , LOT#: UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 34 YR
• Patient Sex: Unknown