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

Model Number VTICMO 13.7

Device Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/26/2023

Event Type  Injury  

Event Description

The reporter indicated the surgeon implanted a 13.7mm vticmo 13.7 implantable collamer lens -10.5/+2.5/91 (sphere/cylinder/axis) into the patients left eye (os) on (b)(6) 2023.The lens was reported as having excessive vaulting, significant reduction of iridocorneal angles.Cause of the event was unknown.On (b)(6) 2024 the lens was replaced with a smaller length lens.This resolved the problem.

Manufacturer Narrative

H6: 4581: significant reduction of irido-corneal angles.H6: 1494-age<21 years old at the time of implantation.Claim#: (b)(4).

• Brand Name: IIMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: 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: jolelene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 19102272
• MDR Text Key: 340102134
• Report Number: 2023826-2024-01525
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/12/2024

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
• Device Operator: Health Professional
• Device Model Number: VTICMO 13.7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/19/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CARTRIDGE MODEL:SFC-45, LOT# UNK.; INJECTOR MODEL: MSI-PF, LOT# UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 20 YR