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

Model Number	VTICM5_12.6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Pupillary Block (2026); Toxic Anterior Segment Syndrome (TASS) (4469); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that the surgeon implanted a 12.6mm vticm5 -9.50/+1.50/090 implantable collamer lens into the patients left eye (os) on (b)(6) 2024.The patient underwent bilateral sequential surgery.Concomitant products used intraoperatively include opegan viscoelastic, the msi injector system, and intracameral antibiotic/solutions (unspecified).Toxic anterior segment syndrome (tass) was diagnosed with presentation of anterior chamber "abscess".Pupil block with elevated iop was also observed.Secondary anterior chamber irrigation and evacuation of visco/fluids was performed.Upon additional surgical and medical intervention, the reported issues improved.Last report on day 13 states patient was recovering with unaided "naked eye" (ucva) vision improved to 1.0 (20/20).The lens remains implanted.In the reporter's opinion the cause of the event is the device.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
H6- health effect- clinical code 4581: anterior chamber abscess.H6 - type of investigation - lens work order search: no similar complaint type events reported for units within the same lot.Manufacturer narrative: a review of the device labeling was completed.Intraocular inflammation, anterior chamber empyema (reported as anterior chamber abscess), pupil block and elevated iop 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.Given the information that upon secondary surgical intervention of residual ovd removal with additional surgical/medical intervention performed, the patient was recovering and visual acuity improved, it is very likely the event was not icl related in origin.(b)(4).
Additional Manufacturer Narrative
Additional data: h6- device history record (dhr) review: based on the results of the investigation, the dhr 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.(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 ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 19641547
• Report Number: 2023826-2024-02766
• Device Sequence Number: 8535197
• Product Code: QCB
• UDI-Device Identifier: 00840311308095
• UDI-Public: 00840311308095
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2024

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: VTICM5_12.6
• 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: 06/03/2024
• Supplement Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/29/2023
• 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 W/FTP, LOT# UNK.; INJECTOR MODEL: MSI-PF, LOT# UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 YR
• Patient Sex: Male