MAUDE Adverse Event Report: STAAR SURGICAL EVO/EVO+VISIAN IMPLANTABLE COLLAMER LENS; PHAKIC TORIC INTRAOCULAR LENS

Model Number	VTICM5 12.6 (-7.0/1.5)
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	04/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6 - type of investigation 3331 - device history record (dhr) review: based on the results of the investigation, all released devices from the associated work order(s), including the suspected device, have been manufactured within established process 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 information: a1 - patient identifier: (b)(6).A2 - date of birth: (b)(6) 1992 a3a - sex: male b3 - date of event: 07-apr-2025 b5 - describe the problem: a healthcare professional reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced tass.Medication was administered and problem resolved.Cause of the event was reported as unknown.D1 - brand name: evo/evo+visian implantable collamer lens d2 - common device name: phakic toric intraocular lens; qcb d4 - additional device information: model number - vticm5 12.6 (-7.0/1.5) catalog number - vticm5 12.6 serial number - (b)(6).Expiration date - 31-dec-2026 primary unique device identifier number - (b)(4).D6a - implant date: (b)(6) 2025 d10 - concomitant medical products and therapy dates: injector model: lioli-24; lot#: unk cartridge model: sfc-45; lot#: unk foam tip plunger: ftp; lot#: unk h4 - device manufacture date: 21-jan-2024 h6 - health effect - impact code (f): 4644 - medication required.H6 - investigation type 4110: lens work order search - no similar complaint event(s) within associated lots were found.(b)(4).
Event or Problem Description
A healthcare professional reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced tass.Medication was administered and problem resolved.Cause of the event was reported as unknown.
Additional Manufacturer Narrative
D2b - unable to leave blank.H11 - 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 led 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).
Event or Problem Description
A health professional reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced tass-like symptoms.Cause of event is unknown.If additional information is received a supplemental medwatch report will be submitted.

• Brand Name: EVO/EVO+VISIAN IMPLANTABLE COLLAMER LENS
• Common Device Name: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 21944347
• Report Number: 2023826-2025-00626
• Device Sequence Number: 9121582
• Product Code: QCB
• UDI-Device Identifier: 00840311308040
• UDI-Public: (01)00840311308040(11)240121(17)261231
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/01/2025

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 Model Number: VTICM5 12.6 (-7.0/1.5)
• Device Catalogue Number: VTICM5 12.6
• Device Lot Number: N/A
• 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: 04/11/2025
• Supplement Date Received by Manufacturer: 07/29/2025; 08/13/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 07/31/2025; 08/25/2025
• Date Device Manufactured: 01/21/2024
• 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: LIOLI-24, LOT#: UNK
• Outcome Attributed to Adverse Event: Other
• Patient Age: 32 YR
• Patient Sex: Male