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

Model Number	VTICMO 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	07/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility representative reported following an implantable collamer lens (icl) implantation procedure, the patient experienced fractive surprise the lens was replaced, and this resolved the problem.Cause of the event was the 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.In addition, it has been noted that the surgeon selected a shorter lens than that initially suggested by ocos.Therefore, there is not enough safety and effectiveness data to support implantation in this patient category.
Additional Manufacturer Narrative
Secondary surgical intervention to remove/replace the lens is identified in the labeling as a known potential adverse event following icl implantation.H6- investigation type 4110: lens work order search-no similar complaints reported for units within the same lot.Claim#(b)(4).
Additional Manufacturer Narrative
Corrected data: b5- a facility representative reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced a refractive surprise.In a separate visit the lens was exchanged with a different toric model, same length, weaker power and the problem was 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.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.D4.- "(b)(4)" udi related data quality updates only.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." should be added.Device evaluation: h3 - type of investigation code: 10- device evaluation: the lens was returned dry in a microcentrifuge vial with residue/debris on product.Visual inspection found haptic broken.Dimensional and functional inspection found the lens to be within specifications.Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER DEVICE (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: 19989164
• Report Number: 2023826-2024-03305
• Device Sequence Number: 18233479
• Product Code: QCB
• UDI-Device Identifier: 00840311322770
• UDI-Public: 00840311322770
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted 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
• Report Date (Section B): 08/14/2024

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: VTICMO 12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2024
• Supplement Date Received by Manufacturer: 09/06/2024
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2024
• 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#1714269; FOAM TIP PLUNGER (FTP), LOT#1719064; INJECTOR MODEL: MSI-PF, LOT#1584323
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 30 YR
• Patient Sex: Unknown