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

Model Number VTICM5_13.2

Device Problems Inadequacy of Device Shape and/or Size (1583); Improper or Incorrect Procedure or Method (2017)

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

Event Date 11/28/2023

Event Type  Injury  

Event Description

The reporter indicated that the surgeon implanted a 13.2mm vticm513.2, -6.0/3.75/165 (sphere/cylinder/axis), implantable collamer lens into the patient's left eye (os) on (b)(6) 2023.Excessive vault was observed.Lens remains implanted.Cause of the event is reported as user error: wong entery of the cylinder sign entered.Additional information has been requested but none has been forthcoming.

Manufacturer Narrative

A4 - unk.A5 - unk.A6 - unk.Claim#(b)(4).

Manufacturer Narrative

H6 - health effect - impact code (f): 4629 corrected to 4627.(b)(4).

Manufacturer Narrative

B5 - as per the follow up email "the lens was corrected" which may imply that a new lens implantation has taken place.No injury reported.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 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: 18701825
• MDR Text Key: 335301300
• Report Number: 2023826-2024-00601
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• Reporter Country Code: TC
• 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,Followup
• Report Date: 04/16/2024

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 Operator: Health Professional
• Device Model Number: VTICM5_13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2024
• Initial Date FDA Received: 02/14/2024
• Supplement Dates Manufacturer Received: 04/16/2024; 04/16/2024
• Supplement Dates FDA Received: 04/16/2024; 04/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/27/2023
• 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 Age: 28 YR
• Patient Sex: Male