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

Model Number	VICM5 12.6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Toxic Anterior Segment Syndrome (TASS) (4469)
Date of Event	03/31/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6- inspection of the returned device identified three foreign particulates on the lens.External laboratory analysis was performed to determine the composition of the foreign material identified on the lens.The foreign particles 1 and 2 on the subject lens were analyzed using scanning electron microscopy with energy-dispersive x-ray spectroscopy (sem-edx) and particle 3 was analyzed using fourier transformation infrared spectroscopy (ftir).Particle 1 was found to be primarily composed of silica iron oxide with trace amounts of carbon, potassium, and calcium.Particle 2 was found to be primarily composed of protein.Particle 3 was found to be primarily composed of aluminum silicates with trace amounts of carbon, iron, sodium, and chlorine.We were not able to conclusively identify the source of the elements identified from the sem-edx and ftir analysis.Claim# (b)(4).
Event or Problem Description
The reporter indicated that a 12.6mm vicm5 -3.50d implantable collamer lens was implanted into the patient's right eye (od) on (b)(6) 2024.Concomitant products used intraoperatively include opegan viscoelastic and the msi injector system.Toxic anterior segment syndrome (tass) was diagnosed.Diagnostics were reportedly performed with results of "found deposits on the implanted lens." patient complained of blurred vision.On day 3 the lens was explanted and the patient remains under observation.In the reporter's opinion the cause of the event is unknown.The lens was returned on (b)(6) 2024.
Additional Manufacturer Narrative
H6-investigation type 4110: lens work order search- three similar complaint event(s) within associated lots were found.A review of the device labeling was completed.Iritis is identified in the labeling as a known potential adverse event 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.Under other defects there is a possibility of (3) foreign matter adhering to the lens surface.In that case, it is necessary to stop inserting the lens, or to remove and reinsert the lens.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#: 734946.
Additional 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).
Additional Manufacturer Narrative
Additional informaton; b5- recieved an update reporting that recovery was observed on day 105 post-op.Around this time a new lens of the same parameters was implanted.Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC 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: 19255919
• Report Number: 2023826-2024-02098
• Device Sequence Number: 2582266
• Product Code: MTA
• UDI-Device Identifier: 00840311300471
• UDI-Public: 00840311300471
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/11/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Model Number: VICM5 12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2024
• Supplement Date Received by Manufacturer: 06/13/2024; 06/11/2024; 09/11/2025
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 06/19/2024; 07/15/2024; 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL: SFC-45: LOT# UNK; FOAM TIP PLUNGER (FTP), LOT# UNK; INJECTOR MODEL: MSI-PF, LOT# UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 YR
• Patient Sex: Male