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

Model Number	VICM5_12.6
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	03/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6 - type of investigation: 4110 - 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.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.Under other defects there is a possibility of (3) foreign matter adhering to the lens surface.Under precautions for use: apply with caution on the following patients (14) history of uveitis.Chronic postop inflammation is typically idiopathic and require extended steroid treatment.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 the surgeon implanted a 12.6mm vicm5 -4.50d implantable collamer lens into the patient's left eye (os) on (b)(6) 2024.The patient underwent bilateral sequential icl surgery.Tass was diagnosed.Diagnostics were performed and deposit and white thread-like substance were observed behind the lens, but no additional treatment was prescribed.It was also reported that onset of problem was 1 month after surgery and that additional procedures were performed: "upper side incision.Horizontal fixation." as of (b)(6) 2024 problem was not resolved and patient was under observation.The reporter states cause of the event was unknown.The lens remains implanted.
Additional Manufacturer Narrative
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: 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 ave; monrovia, CA 91016
• MDR Report Key: 19105649
• Report Number: 2023826-2024-01598
• Device Sequence Number: 7736841
• Product Code: MTA
• UDI-Device Identifier: 00840311300495
• UDI-Public: 00840311300495
• 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): 03/22/2024

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: VICM5_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: 03/22/2024
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 04/15/2024
• Supplement Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2023
• 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 MODEL-FTP, LOT#-UNK; INJECTOR MODEL-MSI-PF, LOT#-UNK
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown