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

Model Number VTICMO12.6

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 10/05/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The reporter indicated the surgeon implanted a 12.6mm vticmo12.6 implantable collamer lens, -16.00/+1.5/001 (sphere/cylinder/axis), in the patients right eye (od), on (b)(6) 2023.The lens was explanted on (b)(6) 2023 due to excessive vaulting.The lens was replaced with a shorter lens and the problem was resolved.The cause of the event was unknown.

• Brand Name: IMPLANTABLE 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: joselene muniz ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 19004903
• MDR Text Key: 338930692
• Report Number: 2023826-2024-01422
• Device Sequence Number: 1
• Product Code: QCB
• UDI-Device Identifier: 00840311322787
• UDI-Public: 00840311322787
• 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: 03/07/2024

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: VTICMO12.6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/27/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR
• Patient Sex: Female