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

Model Number VTICM513.2

Device Problems Improper or Incorrect Procedure or Method (2017); No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/16/2023

Event Type  Injury  

Event Description

The reporter indicated that a 13.2mm vticm513.2 implantable collamer lens of -9.5/1.0/064 (sphere/cylinder/axis) lens tore/broke during injection/delivery into the patient's right eye (od).The haptics are damaged.The lens remains implanted.Cause of the event was user error.

Manufacturer Narrative

A4-a6:unk.H6: user error.Claim#: (b)(4).

Manufacturer Narrative

B5 - the reporter indicated that a 13.2mm vticm513.2 implantable collamer lens of -9.5/1.0/064 (sphere/cylinder/axis) lens tore/broke during injection/delivery into the patient's right eye (od) on (b)(6) 2023.Haptics are damaged.On (b)(6) 2024 the lens was exchanged with a same length lens and the problem resolved.Cause of the event was user error with no device causality.Claim#: (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia 91016
• Manufacturer (Section G): STAAR SUGICAL COMPANY; 1911 walker avenue; monrovia 91016
• Manufacturer Contact: joselene muniz ; 800 royal oaks dr.; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 17715163
• MDR Text Key: 323009054
• Report Number: 2023826-2023-03903
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 08/25/2023

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: VTICM513.2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2023
• Initial Date FDA Received: 09/08/2023
• Supplement Dates Manufacturer Received: 01/12/2024
• Supplement Dates FDA Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2020
• 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; FOAM TIP PLUNGER - LOT# UNK; INJECTOR MODEL: MSI-PF - LOT# UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 21 YR
• Patient Sex: Female