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

Model Number VTICM5 13.2

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

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

Event Date 12/20/2023

Event Type  Injury  

Manufacturer Narrative

A review of the device labeling was completed.Iritis is identified in the labeling as a known adverse event after icl implantation.The dfu states potential adverse events can include iritis (iridocyclitis) and may require secondary surgery.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.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.Even though the causality was attributed to the device an exact cause could not be determined as the event could be multifactorial in nature including patient and/or procedure related factors.Investigation type 4110: lens work order search- one similar complaint event(s) within associated lots were found.(b)(4).

Event Description

The reporter indicated that a 13.2mm vticm5 implantable collamer lens of -6.50/1.00/180 (sphere/cylinder/axis) was implanted into the patient's left eye (os) on (b)(6) 2023 as an exchange lens.The surgeon suspected toxic anterior segment syndrome (tass).Diagnostic cultures were not performed.Opegan ocular viscoelastic device was used for the case.No loss of visual acuity was reported.The lens remains implanted.In the reporter's opinion the cause of this event was due to the device.See mfr# 2024-00615 for initial lens.

Manufacturer Narrative

H6- method code 3331: device history record (dhr) review: based on the results of the investigation, all released devices from the associated work orders(s), including the suspected device, have been manufactured within established parameters; and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.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: 18725352
• MDR Text Key: 335716570
• Report Number: 2023826-2024-00616
• Device Sequence Number: 1
• Product Code: QCB
• UDI-Device Identifier: 00840311311118
• UDI-Public: 00840311311118
• 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
• Report Date: 01/17/2024

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: VTICM5 13.2
• 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: 01/17/2024
• Initial Date FDA Received: 02/16/2024
• Supplement Dates Manufacturer Received: 02/27/2024
• Supplement Dates FDA Received: 03/12/2024
• Date Device Manufactured: 10/19/2023
• 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 (FTP), LOT# UNK; INJECTOR MODEL-MSI-PF, LOT#-UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR