MAUDE Adverse Event Report: STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS (ICL); Phakic toric intraocular lens

Model Number	VTICM5 13.2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted a 13.2mm vticm5_13.2; -10.00/1.0/112 (sphere/cylinder/axis) implantable collamer lens into the patient's eye.The lens was exchanged with a backup lens due to the initial lens implanted upside down.There was no patient injury.No post exchange data was provided.Additional information was requested but has not been provided to date.

• 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 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 19288414
• Report Number: 2023826-2024-02052
• Device Sequence Number: 20623545
• Product Code: QCB
• UDI-Device Identifier: 00841542116572
• UDI-Public: 00841542116572
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/10/2024

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 Expiration Date: 04/30/2024
• Device Model Number: VTICM5 13.2
• 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: 04/19/2024
• Initial Report FDA Received Date: 05/10/2024
• Date Device Manufactured: 05/12/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown