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

Model Number	VICMO12.6
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	03/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A4-a6:unk.H6: work order search: one similar complaint within associated lots were found.Claim# (b)(4), fellow right eye (od).Manufacturer narrative: a review of the device labeling was completed.Anterior chamber empyema, fibrin precipitation, and iritis 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.Claim# (b)(4).
Event or Problem Description
The reporter indicated that a 12.6mm vicmo -15.00d implantable collamer lens was implanted into the patient's right eye (os) on (b)(6) 2024.Same day bilateral icl implantation was performed.Concomitant products used intraoperatively include opegan viscoelastic and the msi injector system.On day 2, the patient experienced significant vision loss and went to hospital where anterior chamber empyema (hypopyon) with a fibrin membrane was noted in the pupillary area.No cultures were taken.Treatment with rinderon subconjunctival injection and sunbeta hourly were given.After anterior chamber irrigation the vision improved to "rv 1.2 (~20/16), lv 1.0 (20/20)".Reportedly, bilateral tass was observed as well.In the reporter's opinion, the device did not fail to perform as intended and cause of the event is unknown.On day 4, the issue was reported as unresolved.The lens remains implanted.
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).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC 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 ; 6263037902
• MDR Report Key: 19068386
• Report Number: 2023826-2024-01281
• Device Sequence Number: 6901181
• Product Code: MTA
• UDI-Device Identifier: 00840311302109
• UDI-Public: 00840311302109
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2024

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: VICMO12.6
• 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: Not provided
• Supplement Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 07/19/2024
• Date Device Manufactured: 11/03/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 23 YR
• Patient Sex: Female