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

Model Number	VICM513.2
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A facility representative reported a implantable collamer lens (icl) tear during injection/delivery into the eye.There was patient contact, but no patient injury.The lens was intraoperatively implanted, removed, and replaced.Cause of the event was the device.The doctor reported a nick on the foot plate of lens.The problem was resolved.Reportedly."patient reports vision is good.".
Additional Manufacturer Narrative
H6: work order search: no similar complaints within associated lots were found.H11: lens serial number, event description, patient, and doctor information were previously reported within claim# (b)(4).Due to reporter clarification provided for unknown information on 10/03/2024, claim# (b)(4) will no longer be a complaint.Claim# (b)(4) will observe all event information from claim# (b)(4) due to earlier notification by reporter.Claim# (b)(4) was previously not reportable based on information initially provided.Claim# 434035.

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 800 royal oaks dr. suite 210; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 20371332
• Report Number: 2023826-2024-04622
• Device Sequence Number: 3688784
• Product Code: MTA
• UDI-Device Identifier: 00841542119467
• UDI-Public: (01)00841542119467(11)230712(17)250630
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2025
• Device Model Number: VICM513.2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/12/2023
• 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: INJECTOR MODEL: LIOLI-24 - LOT# FCK2607
• Patient Age: 24 YR
• Patient Sex: Male