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

Model Number	VICMO 13.2 (-16)
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6 - work order search: another similar complaint was reported for units within the same lot.H11: excessive vault is identified in the labeling as a known potential adverse event following icl implantation.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 and significant reduction of irido-corneal angles.The lens remained implanted.Additional information has been requested but none has been forthcoming.There are multiple 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 Manufacturer Narrative
Corrected data: b1: adverse event.H1: serious injury.Claim # (b)(4).
Additional Manufacturer Narrative
Additional information: claim is not reportable and previous medwatch reports should be disregarded due to new information provided.Claim#: (b)(4).
Additional Manufacturer Narrative
H11 - new information received again made this report medwatch reportable.Disregard previous supplemental indicating report is n/a.H6 - health effect clinical code: 4581 - significant reduction of irido-corneal angles.H6 - type of investigation 3331 - device history record (dhr) review: based on the results of the investigation, all released devices from the associated work order(s), including the suspected device, have been manufactured within established process parameters and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.H6 - type of investigation: 4110 - lens work order search: one similar complaint type events reported for units within the same lot.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.Claim#: (b)(4).
Event or Problem Description
A facility representative reported that an implantable collamer lens was implanted into the patient's eye.The patient experienced excessive vaulting and significant reduction of irido-corneal angles.The lens was explanted and replaced with a shorter length lens.The problem was resolved.The cause of the event was reported as the device.

• 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 ; 6263037902
• MDR Report Key: 21097527
• Report Number: 2023826-2025-00036
• Device Sequence Number: 21125058
• Product Code: MTA
• UDI-Device Identifier: 00840311302536
• UDI-Public: (01)00840311302536(11)240928(17)270831
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/10/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: VICMO 13.2 (-16)
• Device Catalogue Number: VICMO 13.2
• 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: 12/23/2024
• Supplement Date Received by Manufacturer: 01/24/2025; 02/25/2025; 06/10/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 02/14/2025; 02/25/2025; 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/28/2024
• 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 # UNK; CARTRIDGE MODEL-SFC-45, LOT#-UNK; FOAM TIP PLUNGER MODEL FTP - LOT # UNK; FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK; INJECTOR MODEL AND LOT # UNK
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 42 YR
• Patient Sex: Female