MAUDE Adverse Event Report: STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS (ICL); PHAKIC TORIC INTRAOCULAR LENS

Model Number	VTICMO_13.7 (- 15.00/4.0)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	07/03/2024
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 refractive surprise an unplanned post op femto-lasik to correct rx: -0,50/-0,50x9 occurred and the lens remains implanted.The cause of event was reported as unknown.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
H6 - type of investigation: 4110 - lens work order search: no similar complaint type events reported for units within the same lot.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.Claim #: (b)(4).
Additional Manufacturer Narrative
H3- supp#1 is not applicable.Claim #(b)(4).
Additional Manufacturer Narrative
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
Corrected data: d6b - in initial mdr is explant date: (b)(6) 2025.Claim#: (b)(4).
Additional Manufacturer Narrative
B5- a facility representative reported that following an implantable collamer lens (icl) implantation procedure the patient experienced refractive surprise an unplanned post op femto-lasik to correct rx: -0,50/-0,50x9 occurred.The lens exchange for a same length lens and the problem resolved.The cause of event was reported as unknown.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.D10: injector model: msi-pf, lot # unk cartridge model: sfc-45, lot# unk foam tip plunger: ftp, lot# unk 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.Claim #(b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• 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 muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 22786191
• Report Number: 2023826-2025-01134
• Device Sequence Number: 15517930
• Product Code: QCB
• UDI-Device Identifier: 00840311333202
• UDI-Public: (01)00840311333202(11)240501(17)270430
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 08/12/2025

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: VTICMO_13.7 (- 15.00/4.0)
• Device Catalogue Number: VTICMO_13.7
• 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: 07/18/2025
• Supplement Date Received by Manufacturer: 08/18/2025; 09/15/2025; 10/24/2025; 01/15/2026
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 09/12/2025; 09/16/2025; 11/18/2025; 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• 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: 38 YR
• Patient Sex: Male