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	05/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6 - work order search: no similar complaint type events were reported for units within the same lot.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 refractive surrpise and refractive change over time.Due to refractive surprise and refractive change overtime, the lens was removed and replaced intraoperatively for a same length lens.The problem was resolved.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.Cause of the event was reported as unknown.
Additional Manufacturer Narrative
D4 - primary unique device identifier (udi) #: (b)(4).H3 - device evaluation: the lens was returned in liquid in a microcentrifuge vial.Visual inspection found no visual damage to the lens.Dimensional and functional inspection found the lens to be within specification.H4 - device manufacture date: 20-dec-2023.Corrected to 17-dec-2023.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: 20137551
• Report Number: 2023826-2024-04103
• Device Sequence Number: 3186973
• Product Code: QCB
• UDI-Device Identifier: 00840311308408
• UDI-Public: (01)00840311308408(11)231217(17)261130(21)T1807875
• 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: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2024

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_12.6
• 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: 08/29/2024
• Supplement Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2023
• 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.; FOAMTIPPLUNGER MODEL#FTP,LOT#UNK.; INJECTOR MODEL#MSI-PF,LOT#UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 32 YR
• Patient Sex: Male