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

Model Number	VTICM5 12.6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	08/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Claim: (b)(4).
Event or Problem Description
A facility representative reported following an implantable collamer lens (icl) implantation procedure, the patient experienced refractive surprise.At a later date, the lens was exchanged for a lens of a different power and the problem resolved.Cause of the event was reported as unknown.A work order search was performed, no similar complaint types were found.
Additional Manufacturer Narrative
E1: (b)(6).E2: yes.E3: physcian.H3 - type of investigation code: 10- device evaluation: the lens was returned in liquid within a microcentrifuge vial.Visual inspection found no visible damage to the lens.Dimensional inspection found the lens to be within original values.H6- investigation type code: 4110- lens work order search-no similar complaint event(s) within associated lots were found.Claim (b)(4).
Additional Manufacturer Narrative
Corrected data: b5.- a facility representative reported following an implantable collamer lens (icl) implantation procedure, the patient experienced refractive surprise.In a separate surgery the lens was exchanged for a lens of a different power and the problem resolved.The cause of the event was reported as unknown.It has been noted that the surgeon selected a different lens size than that initially suggested by the icl calculation software.Therefore, there is not enough safety and effectiveness data to support implantation in this patient category.E1."usa" should be removed and "japan" should be added.H4."on (b)(6) 2024" should be removed and "on (b)(6) 2024" should be added.H3.Type of investigation code: 10- "device evaluation: the lens was returned in liquid within a microcentrifuge vial.Visual inspection found no visible damage to the lens.Dimensional inspection found the lens to be within original values." should be removed and "device evaluation: the lens was returned in a microcentrifuge vial with moisture and residue/debris on product.Visual inspection found no visible damage.Dimensional and functional inspection found the lens to be within specifications." should be added.H11- "manufacturer narrative: 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." should be added.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 ; 800 royal oaks dr.; suite: 210; monrovia, CA 91016 ; 8002927902
• MDR Report Key: 21404947
• Report Number: 2023826-2025-00269
• Device Sequence Number: 15526619
• Product Code: QCB
• UDI-Device Identifier: 00840311307784
• UDI-Public: (01)00840311307784(11)240409(17)270331
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/27/2025

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
• 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: 01/27/2025
• Supplement Date Received by Manufacturer: 04/02/2025; 05/19/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 04/23/2025; 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2024
• 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-FTP, LOT# UNK.; INJECTOR MODEL-MSI-PF, LOT# UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR
• Patient Sex: Female