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

Model Number	VTICM_12.6
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 implantatble collamer lens (icl) implantation procedure, the patient experienced excessive vault.The lens was implanted, removed and replaced intraoperatively for a shorter length lens.This resolved the problem.Cause of the event was reported as unknown.
Additional Manufacturer Narrative
D4 - model #: vticm_12.6 corrected to vticm5_12.6.Claim #(b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)PHAKIC TORIC INTRAOCULAR LENS
• 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: 19809768
• Report Number: 2023826-2024-03252
• Device Sequence Number: 8389367
• Product Code: QCB
• UDI-Device Identifier: 00840311308347
• UDI-Public: 00840311308347
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2024

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: VTICM_12.6
• 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: 07/19/2024
• Supplement Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 10/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/11/2024
• 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-UNK,LOT#-UNK
• Patient Age: 20 YR
• Patient Sex: Female