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

Model Number	VTICM5 12.6(-11.5/2.5)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer 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.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 healthcare professional reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced residual hyperopia and astigmatism.Due to residual hyperopia and astigmatism the lens was repositioned.The lens remains implanted.Cause of event was reported as unknown.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
H6 - work order search: one additional similar complaint type event within associated lots was found.Claim #(b)(4).
Additional Manufacturer Narrative
B5 - a healthcare professional reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced lens rotation not associated to a low vault.Due to lens rotation not associated to a low vault, the lens was repositioned.This did not resolve the problem.Lens remains implanted.Cause of the event reported as unknown.Claim # (b)(4).
Additional Manufacturer Narrative
B4.Date of this report: 19-dec-2025 corrected to 19-dec-2024 in initial mdr h11: remove: 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 from initial mdr.Claim # (b)(4).
Additional Manufacturer Narrative
B5 - a healthcare professional reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced lens rotation not associated to a low vault.Due to lens rotation not associated to a low vault, the lens was repositioned.This did not resolve the problem.The lens was explanted.A replacement lens was implanted.This resolved the problem.Cause of the event was reported as unknown g6 - 6.Type of report: 30-day missing from initial mdr.Claim #(b)(4).
Additional Manufacturer Narrative
H3 - device evaluation: the lens was returned in a vial in liquid.Visual inspection found no visible damage to the lens but foreign material on the lens surface, specifically fibers.Dimensional inspection found the lens to be within specifications.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 SUGICAL COMPANY; 1911 walker avenue; monrovia 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 21400126
• Report Number: 2023826-2025-00265
• Device Sequence Number: 9318211
• Product Code: QCB
• UDI-Device Identifier: 00840311308699
• UDI-Public: (01)00840311308699(11)240315(17)270228
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 12/19/2025

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
• Device Model Number: VTICM5 12.6(-11.5/2.5)
• Device Catalogue Number: VTICM5 12.6
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2025
• Supplement Date Received by Manufacturer: 03/10/2025; 03/10/2025; 05/09/2025; 05/21/2025; 06/30/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 04/17/2025; 04/28/2025; 05/09/2025; 05/30/2025; 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2024
• 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.; FOAM TIP PLUNGER-MODEL-UNK, LOT#-UNK.; INJECTOR MODEL-MSI-MSI-PF, LOT#-UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female