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

Model Number VICM5_12.6

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

Patient Problem Toxic Anterior Segment Syndrome (TASS) (4469)

Event Date 03/02/2024

Event Type  Injury  

Event Description

The reporter indicated that the surgeon implanted a 12.6mm vicm5 -4.00d implantable collamer lens into the patient's right eye (od) on (b)(6) 2024.The patient underwent bilateral sequential icl surgery.The msi injector delivery system was used but the viscoelastic type used during procedure was not provided.Tass was diagnosed.Anterior chamber irrigation/evacuation of visco/fluids was performed.Diagnostics were performed and deposits were observed on both side of the lens so, intensive steroid treatment was prescribed.It was also reported that onset of problem was 1 month after surgery and that additional procedures were performed: "ear side incision.Horizontal fixation." as of (b)(6) 2024 problem was not resolved and patient was under observation.The lens remains implanted.The reporter states the cause of the event was unknown.

Manufacturer Narrative

H6 - type of investigation: 4110 - lens work order search: no similar complaint type events reported for units within the same lot.Manufacturer narrative: a review of the device labeling was completed.The dfu provides the surgeon instruction for complete ovd removal.Precaution: (6) after inserting this product, aspirate the viscoelastic substance completely from inside the eye.Do not use highly viscous viscoelastic substances that are difficult to aspirate completely.Under other defects there is a possibility of (3) foreign matter adhering to the lens surface.Under precautions for use: apply with caution on the following patients (14) history of uveitis.Chronic postop inflammation is typically idiopathic and require extended steroid treatment.Toxic anterior segment syndrome (tass) is an acute sterile postoperative inflammation that can occur after uncomplicated or complicated intraocular surgery.While improper sterilization and contamination of surgical instruments remains the most common risk factor associated with tass, ocular viscoelastic, and improper preparation of antibiotics for intracameral injection may also lead to tass.An exact cause could not be determined as the event could be multifactorial in nature including patient and/or procedure related factors.Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC 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 ave; monrovia, CA 91016
• MDR Report Key: 19105648
• MDR Text Key: 340157331
• Report Number: 2023826-2024-01597
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00840311300488
• UDI-Public: 00840311300488
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/22/2024

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: VICM5_12.6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2024
• Initial Date FDA Received: 04/15/2024
• Date Device Manufactured: 08/10/2023
• 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 MODEL-FTP, LOT#-UNK; INJECTOR MODEL-MSI-PF, LOT#-UNK
• Patient Outcome(s): Required Intervention