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

Model Number	VTICM5_13.2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	01/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Ch a facility representative reported that following an implantable collamer lens (icl) procedure, the patient experienced refractive surprise.The lens was repositioned but that did not resolve the problem.Lens remains implanted.The cause of the event was reported as unknown.
Additional Manufacturer Narrative
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.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).
Additional Manufacturer Narrative
H3 - device evaluation is required but has not yet been performed.B5 - a facility representative reported that following an implantable collamer lens (icl) procedure, the patient experienced refractive surprise.The lens was repositioned but that did not resolve the problem.The lens exchange for the same length lens and the problem resolved.Remains implanted.The cause of the event was reported as unknown.(b)(4).
Additional Manufacturer Narrative
B5 - a facility representative reported that following an implantable collamer lens (icl) procedure, the patient experienced refractive surprise.The lens was repositioned but that did not resolve the problem.The lens explanted and replaced for the same length lens and the problem resolved.The cause of the event was reported as unknown.H3 - device evaluation: the lens was returned in a dry microcentrifuge vial with residue/debris on product.Visual inspection found the haptic broken and bent and foreign material on lens surface such as fibre.Dimensional inspection found the lens to be within specifications.Functional inspection found that the returned lens did not meet original values measured at the time of manufacturing.H6 - type of investigation: 4110 - lens work order search: no similar complaint type events reported for units within the same lot.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.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: 21400280
• Report Number: 2023826-2025-00264
• Device Sequence Number: 9382378
• Product Code: QCB
• UDI-Device Identifier: 00840311312030
• UDI-Public: (01)00840311312030(11)240819(17)270731
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/23/2025

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: VTICM5_13.2
• Device Catalogue Number: N/A
• 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): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2025
• Supplement Date Received by Manufacturer: 08/04/2025; 09/04/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 09/03/2025; 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2024
• 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: 32 YR
• Patient Sex: Female