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

Model Number	VTICM5_13.2
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A facility representative reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced excessive vault.The lens remains implanted.Cause of the event was reported as unknown.Per the reporter "the doctor has seen the patient on week 1, and the vault had gone down to 900 microns.On week 2 it was up again to 1050 microns, but the angles were fine and pt was happy.The doctor has planned another follow-up on month 1 and month 3".She already ordered replacements (was done on day 1), but she will wait and see if it's necessary.Additional information was requested.No further information is available at this time.This file will be re-opened if additional information is provided.
Additional Manufacturer Narrative
H6: work order search: no additional similar complaint type events within associated lots were found.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
Initial mdr is n/a.Claim #(b)(4).
Additional Manufacturer Narrative
E1 - name and address: usa corrected to (b)(6).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 SUGICAL COMPANY; 1911 walker avenue; monrovia 91016
• Manufacturer Contact: joselene muniz ; 800 royal oaks dr. suite:210; monrovia, CA 91016
• MDR Report Key: 20453143
• Report Number: 2023826-2024-04637
• Device Sequence Number: 17903601
• Product Code: QCB
• UDI-Device Identifier: 00840311312191
• UDI-Public: (01)00840311312191(11)240330(17)270228
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/01/2024

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
• Device Model Number: VTICM5_13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/01/2024
• Supplement Date Received by Manufacturer: 11/01/2024; 01/07/2025
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 11/11/2024; 01/07/2025
• Date Device Manufactured: 03/30/2024
• 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
• Patient Age: 36 YR
• Patient Sex: Male