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

Model Number	VICM5_13.2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Endophthalmitis (1835)
Date of Event	06/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2 mm vicm5 -11.5d implantable collamer lens into the patient`s right eye(od) on (b)(6) 2024.Msi injector system and provisc as viscosurgical device(ovd) were used during surgery.Clinical signs of endophthalmitis ("hypopyon" and "conjunctival hyperemia") were observed on (b)(6) 2024.Humor aqueous was sent for analysis and results were pending.Additional treatment performed included intraocular injection of steroid and antibiotic.As of (b)(6) 2024 the patient status of the eye was reported to improve "absence of hypopyon" and "slight improvement of visus." the cause of the event was reported as unknown.The lens remains implanted.
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.Complications and adverse reactions: adverse reactions and complications due to, or following surgery and implantation of any evo|evo+ icl may include, but are not limited to: intraocular infection, uveitis/iritis, hypopyon, conjunctival irritation.Warnings complete removal of viscoelastic from the eye after completion of the surgical procedure is essential.Staar surgical recommends a low molecular weight 2% hydroxypropyl methylcellulose (hpmc) or dispersive, low viscosity ophthalmic viscosurgical device.Etiology and pathology of endophthalmitis were not provided to date.Provisc (sodium hyaluronate) is not the ovd that was recommended by staar surgical labeling.Therefore, 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).
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.(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 SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 19645837
• Report Number: 2023826-2024-02865
• Device Sequence Number: 12696243
• Product Code: MTA
• UDI-Device Identifier: 00840311300969
• UDI-Public: 00840311300969
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 06/06/2024

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_13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• 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: 06/06/2024
• Supplement Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 10/17/2024
• Date Device Manufactured: 01/18/2024
• 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: Required Intervention
• Patient Age: 30 YR
• Patient Sex: Male