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

Model Number VTICM512.6

Device Problem No Apparent Adverse Event (3189)

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

Event Date 02/17/2024

Event Type  malfunction  

Manufacturer Narrative

A4-a6:unk.H6: work order search: no similar complaints within associated lots were found.Manufacturers narrative: a review of the device labeling was completed.Iritis and cells in the anterior chamber are identified in the labeling as known potential adverse events following icl implantation.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.An exact cause could not be determined as the event could be multifactorial in nature including patient and/or procedure related factors.Requests for additional information has not been forthcoming.Claim#(b)(4).

Event Description

The reporter indicated that a 12.6mm vticm512.6 implantable collamer lens of a -8.5/1.5/010 (sphere/cylinder/axis) was implanted into the patient's left eye (os) on (b)(6) 2024.Toxic anterior segment syndrome (tass) was observed on day 1.The patient reportedly had difficulty seeing through the haze and occasionally experienced pain behind the eye.There is no report of elevated iop.Information provided on (b)(6) 2024 states a bcva of 20/29 as the problem is not resolved.The lens remains implanted.In the reporter's opinion, the cause of the event is unknown.

• 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: 18979579
• MDR Text Key: 338614239
• Report Number: 2023826-2024-01083
• Device Sequence Number: 1
• Product Code: QCB
• UDI-Device Identifier: 00840311308071
• UDI-Public: 00840311308071
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030017
• 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
• Report Date: 03/03/2024

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: VTICM512.6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2024
• Initial Date FDA Received: 03/26/2024
• Date Device Manufactured: 08/31/2023
• 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-PF - LOT# UNK
• Patient Age: 24 YR
• Patient Sex: Female