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

Model Number	VICM5 13.2
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	04/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A4-a6: unk h6 - type of investigation: 4110 - lens work order search: no similar complaint type events reported for units within the same lot.Claim# (b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted a 13.2mm vicm5 -5.00d implantable collamer lens into the patient's right eye (od) on (b)(6) 2024.The patient underwent bilateral implantation of icls.Concomitant products used intraoperatively include purified sodium hyaluronate viscoelastic and the msi injector system.Approximately 7 weeks later, toxic anterior segment syndrome (tass) was diagnosed (od only) and the lens was explanted.The information provided describes persistent inflammation.No diagnostic tests were performed.Patient management included "washing", steroid and antibiotic treatment.The patient remains under observation with the issue unresolved.In the reporter's opinion the cause of the event was unknown.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
Additional information: h6:3331: device history review:device history record review found associated source lots were manufactured within established parameters and limits.Corrective and/or preventive actions are being addressed through capa-24-001 and this issue will continue to be tracked and trended as part of the normal device safety committee meetings and capa monitoring.H6:4112: laboratory analysis: inspection of the returned device identified particulates on the lens.External laboratory analysis was performed to determine the composition of the foreign materials identified on the lens.Specifically, four particles were analyzed: particle 1 and particle 4 from the lens underwent fourier transform infrared spectroscopy (ftir) analysis, while particles 1, 2, and 3 were examined using scanning electron microscopy with energy-dispersive x-ray spectroscopy (sem-edx).Particle 1 was found to be primarily composed of protein, iron rust, and calcium carbonate with trace amounts of silicon, aluminum, sulfur, zinc, manganese, phosphorus, and magnesium.Particle 2 was found to be primarily composed of iron rust and fluorocarbon with trace amounts of silicon, calcium, chromium, magnesium, aluminum, phosphorus, and sulfur.Particle 3 was found to be primarily composed of silicates with trace amounts of carbon, calcium, titanium, and iron.Particle 4 was found to be primarily composed of protein.Results were unable to conclusively identify the source of the elements identified from the sem-edx and ftir analysis claim# (b)(4).
Additional Manufacturer Narrative
A 3a: female.B5 - in a separate surgery the lens was replaced with a same model and length lens.D4 - (b)(4).H4 - 26-oct-2023 corrected to 23-oct-2023.H6 - health effect - impact code (f): 4644.Claim #(b)(4).
Additional Manufacturer Narrative
B5 - the reporter indicated that following an implantable collamer lens (icl) implantation procedure, the patient experienced toxic anterior segment syndrome (tass).Toxic anterior segment syndrome (tass) was observed.The lens was explanted.Reportedly treatment was performed as "washing, steroids, antibiotics".A replacement lens of the same model and length was implanted.Reportedly, "the patient had recovered by day 83 post-op.At this time the bcva was 20/13".Cause of the event was marked as unknown.Claim #(b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC INTRAOCULAR LENS, PRODUCT CODE: MTA
• 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: 19515588
• Report Number: 2023826-2024-02360
• Device Sequence Number: 3266416
• Product Code: MTA
• UDI-Device Identifier: 00840311300839
• UDI-Public: (01)00840311300839(11)231023(17)260930(21)S2206455
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/31/2024

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 13.2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2024
• Supplement Date Received by Manufacturer: 07/11/2024; 09/25/2024; 09/11/2025
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 07/18/2024; 09/25/2024; 10/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/23/2023
• 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: 31 YR
• Patient Sex: Female