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	02/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated a 12.6mm vicm5 -5d implantable collamer lens (icl) was implanted into the patient's right (od) on (b)(6) 2024.The patient underwent bilateral sequential surgery.On the same surgery date, toxic anterior segment syndrome (tass) was diagnosed bilaterally.Concomitant products used intraoperatively include opegan viscoelastic, imipenem cilastatin, and the msi injector system.Patient was treated per standard protocol.Diagnostic cultures were not performed.The reporter states the cause of this event is unknown.Per completed tass report form it is unknown if there were changes to instrument sterilization process (detergents, duration, machines, etc).Last report on 25-aug-2024 states the lens is scheduled for replacement and the issue is not resolved.The lens remains implanted.No further information is available at this time.If additional information is received, a supplemental medwatch report will be submitted.
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/uveitis/endophthalmitis are identified in the labeling as known 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.(10) this product should not be immersed in anything other than commonly used intraocular irrigation fluids or viscoelastic substances.Under how to use: (8) completely remove the viscoelastic substance from the eye and miosis the pupil.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.Given the bilateral presentation, an exact cause could not be determined as the event could be multifactorial in nature including patient and/or procedure related factors." claim#: 737223.
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.(b)(4).
Additional Manufacturer Narrative
Additional information: b5- updated complaint information was received indicating, inflammatory recovery was observed at 180 days postoperatively.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 SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 20281186
• Report Number: 2023826-2024-04359
• Device Sequence Number: 7563983
• Product Code: MTA
• UDI-Device Identifier: 00840311300501
• UDI-Public: (01)00840311300501(11)231022(17)260930
• 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): 08/28/2024

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
• 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: 08/28/2024
• Supplement Date Received by Manufacturer: 11/26/2024; 02/12/2026
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 12/04/2024; 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/22/2023
• 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 (FTP), LOT# UNK.; INJECTOR MODEL: MSI-PF, LOT# UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 22 YR
• Patient Sex: Female