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

Model Number VTICM513.2

Device Problems Misfocusing (1401); Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)

Patient Problem Blurred Vision (2137)

Event Date 08/17/2023

Event Type  Injury  

Event Description

The reporter indicated that a 13.2mm vticm513.2 implantable collamer lens of -13.0/2.0/82 (sphere/cylinder/axis) was implanted into the patient's left (os) on (b)(6) 2023.On (b)(6) 2023, the lens was exchanged for a longer length lens due to lens rotation not associated to low vault and refractive surprise.The problem was resolved.Cause of the event was user error.

Manufacturer Narrative

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

Manufacturer Narrative

Corrected data: h6: 4627-explant.Claim# (b)(4).

Manufacturer Narrative

Additional information: h3 - device evaluation: the lens was returned in liquid in a microcentrifuge vial with residue/debris on the lens.Visual inspection found the haptic broken and residue on the lens, specifically fibre.Dimensional and functional inspections 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 ; 800 royal oaks dr. suite:210; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 17846529
• MDR Text Key: 324625647
• Report Number: 2023826-2023-04241
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 09/20/2023

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: VTICM513.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2023
• Initial Date FDA Received: 09/29/2023
• Supplement Dates Manufacturer Received: 11/24/2023; 12/21/2023
• Supplement Dates FDA Received: 12/20/2023; 12/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2022
• 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# 1652251; FOAM TIP PLUNGER - LOT# 1643229; INJECTOR MODEL: MSI-PF - LOT# 1572654
• Patient Outcome(s): Required Intervention
• Patient Age: 21 YR
• Patient Sex: Male