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

Model Number VTICM5 12.6

Device Problems Off-Label Use (1494); Device Dislodged or Dislocated (2923)

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

Event Date 09/20/2023

Event Type  Injury  

Manufacturer Narrative

Additional information: h6-device code 1494: off-label use : pre -existing: progressive myopia.Claim# (b)(4).

Event Description

The reporter indicated that a 12.6mm vticm5 12.6 implantable collamer lens of -11.50/2.0/022 (sphere/cylinder/axis) was implanted into the patient's right eye (od) on (b)(6) 2023.Lens rotation was observed.On (b)(6) 2023 the lens was exchanged for a longer length lens and the problem was resolved.

Manufacturer Narrative

H3-device evaluation: lens returned in a microcentrifuge vial dry with moisture and residue/debris on product.Visual inspection no visual damage to lens.Dimensional inspection found the lens to be within specifications.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 SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA ; 6263037902
• MDR Report Key: 18947108
• MDR Text Key: 338185171
• Report Number: 2023826-2023-05384
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/06/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: VTICM5 12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/06/2023
• Initial Date FDA Received: 03/20/2024
• Supplement Dates Manufacturer Received: 12/27/2023
• Supplement Dates FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2022
• 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# 1583675.; FOAM TIP PLUNGER (FTP), LOT# 1654310.; INJECTOR MODEL: MSI-TF, LOT# 1635523.
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR
• Patient Sex: Male