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

Model Number	VTICM512.6
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Toxic Anterior Segment Syndrome (TASS) (4469)
Date of Event	02/17/2024
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional Manufacturer Narrative
H6: type of investigation 3331 - device history record review indicates that the product has been manufactured within the established process parameters and that there is no indication that the manufacturing and/or processing of the device contributed to the complaint issue.Claim# (b)(4).
Additional Manufacturer Narrative
B5: inflammatory recovery was observed eight days post-implantation.Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: 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 ; 6263037902-2394
• MDR Report Key: 18979579
• Report Number: 2023826-2024-01083
• Device Sequence Number: 17762095
• Product Code: QCB
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2026
• Device Model Number: VTICM512.6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2024
• Supplement Date Received by Manufacturer: 06/04/2024; 03/27/2026
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 07/19/2024; 08/27/2026
• Date Device Manufactured: 08/31/2023
• 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 - LOT# UNK; INJECTOR MODEL: MSI-PF - LOT# UNK
• Patient Age: 24 YR
• Patient Sex: Female