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

Model Number VTICMO 13.7

Device Problems Off-Label Use (1494); Inadequacy of Device Shape and/or Size (1583); Patient-Device Incompatibility (2682); No Apparent Adverse Event (3189)

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

Event Date 08/11/2023

Event Type  malfunction  

Manufacturer Narrative

A4-a6:unk h6: off-label keratoconus patient-related-factor (b)(4).

Event Description

The reporter indicated that a 13.7mm vticm513.7 implantable collamer lens of a -6.50/1.0/105 (sphere/cylinder/axis) lens was implanted into the right eye (od) of a patient with pre-existing keratoconus on (b)(6) 2023.Exessive vault is observed.Cause of the event is a patient-related-factor.Reportedly, "the patient is doing very well because the anterior chamber is large.".

Manufacturer Narrative

Corrected data: the reporter indicated the surgeon implanted a 13.7mm vticmo 13.7 implantable collamer lens of diopter -6.5/+1.0/100 (sphere/cylinder/axis) into the patient's right eye (od) on (b)(6) 2023.The patient experienced an excessive vault.The lens remains implanted.Additional information provided: "the patient is doing very well because the anterior chamber is large (3.75 mm and the iop is 15): but my decision is to go with a lens with smaller size in the other eye to avoid having similar vault and maybe even larger vault".The reporter indicated the cause of the event is a patient related factor.D4.Model #- "vticm5_ 13.7" should be removed and "vticmo 13.7" should be added.D6b.(b)(6) 2024" should be removed.H6- medical device problem code: "1494- off label use (keratoconus)" and "3189" should be added.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 91016 ; 6263037902
• MDR Report Key: 18627853
• MDR Text Key: 334632523
• Report Number: 2023826-2024-00463
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• Reporter Country Code: LE
• 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
• Report Date: 01/24/2024

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: VTICMO 13.7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2024
• Initial Date FDA Received: 02/01/2024
• Supplement Dates Manufacturer Received: 03/07/2024
• Supplement Dates FDA Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2023
• 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
• Treatment: CARTRIDGE MODEL: SFC-45 - LOT# UNK; FOAM TIP PLUNGER - LOT# UNK; INJECTOR MODEL: MSI-TF - LOT# UNK
• Patient Age: 26 YR
• Patient Sex: Male