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

Model Number	VICM512.6
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Toxic Anterior Segment Syndrome (TASS) (4469)
Date of Event	02/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that a 12.6mm vicm512.6 implantable collamer lens of -6.50 diopter was implanted into the patient's right eye (od) on (b)(6) 2024.Concomitant products used intraoperatively include opegan viscoelastic and the msi injection system.On the same day toxic anterior segment syndrome (tass) was observed.Management included steroid "medication, eye drops" and subconjunctival injection.The lens remains implanted.The problem was resolved.
Additional Manufacturer Narrative
A4-a6:unk.H6: work order search: no similar complaints within associated lots were found.Manufacturer's narrative: a review of the device labeling was completed.Iritis 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.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.(b)(4).
Additional Manufacturer Narrative
Correction: b1 - adverse event.B2 - required intervention to prevent permanent impairment/damage.H1 - serious.Claim# (b)(4).
Additional Manufacturer Narrative
H3: 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.(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 ; 800 royal oaks dr. suite: 210; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 19047486
• Report Number: 2023826-2024-01282
• Device Sequence Number: 8565997
• Product Code: MTA
• UDI-Device Identifier: 00840311300532
• UDI-Public: 00840311300532
• 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,Followup
• Report Date (Section B): 03/13/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2026
• Device Model Number: VICM512.6
• 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: 06/12/2024; 06/27/2024
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 06/24/2024; 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2023
• 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: 29 YR
• Patient Sex: Male