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

Model Number VTICMO13.2

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); Blurred Vision (2137); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

The reporter indicated that the surgeon implanted a 13.2mm vticmo13.2; -5.00/2.5/117 (sphere/cylinder/axis) implantable collamer lens into the patient's right eye (od) on (b)(6) 2023.The surgeon reports post-op she had some uncorrected cyl in her right eye +0.75/-1.25 x7, her icl was not in the correct position, it was at 20 degrees instead of the intended 3 degrees.I used astigmatismfix.Com to calculate the correct position of the icl.Astigmatismfix.Com suggested that the lens be at 65 degrees so i dialled it to that position.This made the astigmatism worse.It was later again reported the lens was repositioned and it was uneventful.The patient is better but not perfect.Lens remains implanted.

Manufacturer Narrative

H6 - type of investigation: 4110 - lens work order search: no similar complaint type events reported for units within the same lot.Claim# (b)(4).

Manufacturer Narrative

B5 - it was later reported that the lens was repositioned on (b)(6) 2024 but this made the problem worse, then on (b)(6) 2024 the lens was repositioned again to it's intended position from the initial calculations and the patient has not returned to the surgeon since.Cause of the event was reported as the device.Claim#: (b)(4).

Manufacturer Narrative

H6: health effect clinical code: 4581 - dilated pupil.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: 18891102
• MDR Text Key: 337508952
• Report Number: 2023826-2024-01186
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/19/2024

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: VTICMO13.2
• 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: Not provided
• Initial Date FDA Received: 03/12/2024
• Supplement Dates Manufacturer Received: 03/25/2024; 04/18/2024
• Supplement Dates FDA Received: 04/02/2024; 04/18/2024
• Date Device Manufactured: 03/29/2023
• 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 Sex: Female