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

Model Number	VICM5 12.1
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	09/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6 - investigation type 4110: lens work order search - no similar complaint event(s) within associated lots were found."a review of the device labeling was completed.Iritis (iridocyclitis), anterior chamber empyema (reported as hypopyon) and fibrin precipitation 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.Per the delivery system dfu: sterilization instructions: after the injector has been properly cleaned, the injector should be pouched to preserve sterility and steam sterilized using the following sterilization cycle: (note: the microstaar injector models msi-tf and msi-pf can be cleaned and sterilized up to 20 times before disposal).Warning staar surgical cartridges, ftps and ftp holders are packaged and sterilized for single use only.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.Opegan is purified sodium hyaluronate manufactured by (b)(4).Literature reports that there are numerous pathogens that are resistant to moxifloxacin.It should be noted that the event could be multifactorial in nature including patient and/or procedure related factors." claim# (b)(4).
Event or Problem Description
A facility representative reported that a 12.1mm vicm5 12.1 -4.00d implantable collamer lens (icl) was implanted into the patient's right eye (od) on (b)(6) 2024.The patient underwent bilateral sequential surgery.Concomitant products used intraoperatively include intracameral moxifloxacin, opegan ovd and the msi injector delivery system.Toxic anterior segment syndrome (tass) was diagnosed.Presentation of hypopyon, fibrin and ac cells were observed.Cultures were not taken for analysis.Antibiotic, steroid and nsaid ophthalmic drops were given for treatment.On day 8 follow up "inflammation continues".The lens remains implanted.In the reporters opinion, the device caused the event and an investigation report was requested.
Additional Manufacturer Narrative
H6- method code 3331: device history record (dhr) review: based on the results of the investigation, all released devices from the associated work orders(s), including the suspected device, have been manufactured within established 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 ; 800 royal oaks dr; suite 210; monrovia, CA
• MDR Report Key: 20493805
• Report Number: 2023826-2024-04757
• Device Sequence Number: 14477265
• Product Code: MTA
• UDI-Device Identifier: 00840311300150
• UDI-Public: (01)00840311300150(11)231109(17)261031
• 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): 09/27/2024

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 Model Number: VICM5 12.1
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2024
• Supplement Date Received by Manufacturer: 12/02/2024
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 12/17/2024
• Date Device Manufactured: 11/09/2023
• 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: FOAM TIP PLUNGER, LOT# 1721583.; MSI-PF, LOT# 1770245.; SFC-45, LOT# 1748674.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 23 YR
• Patient Sex: Female