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

Model Number	VTICM5_13.2 (-5.0/1.5)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Corneal Stromal Edema (1824); Inflammation (1932); Toxic Anterior Segment Syndrome (TASS) (4469)
Date of Event	02/26/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.H6: investigation type 4110: a lens work order search was performed.No additional similar complaint type events within associated lots were found.Inflammation 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.Claim: (b)(4).
Event or Problem Description
A facility representative reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced stromal edema, inflammation and symptoms resembling tass.Steroid drops, prednisone tablets and maxitrol ointment were provided for medical management.The lens remains implanted, and the problem was noted as resolved.Cause of the event was reported as unknown.
Additional Manufacturer Narrative
B5 - a facility representative reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced toxic anterior segment syndrome and corneal edema.Due to toxic anterior segment syndrome and corneal edema, the case was managed medically by increased use on steroid drops and added prednisone tablets po to regimen along with maxitrol ointment at bedtime.The lens remains implanted.The problem was resolved.The cause of the event was reported as unknown.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).

• 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: 24721924
• Report Number: 2023826-2026-00506
• Device Sequence Number: 18678260
• Product Code: QCB
• UDI-Device Identifier: 00840311311361
• UDI-Public: (01)00840311311361(11)251211(17)281130
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2026

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_13.2 (-5.0/1.5)
• Device Catalogue Number: VTICM5_13.2
• 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: 03/02/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2025
• 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#: 1840488.; FOAM TIP PLUNGER: FTP, LOT#: UNKNOWN.; INJECTOR MODEL: MSI-PF, LOT#: UNKNOWN.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 31 YR
• Patient Sex: Male