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)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6 - work order search: no additional similar complaint type events within associated lots were found.A review of the device labeling was completed.Iritis (iridocyclitis), and anterior chamber cells are identified in the labeling as known potential adverse events following icl implantation.The dfu states precautions to physicians (10) this product should not be immersed in anything other than commonly used intraocular irrigation fluids or viscoelastic substances.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.Opegan was used during the procedure and is a viscous cohesive of purified sodium hyaluronate manufactured by seikagaku.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.An exact cause could not be determined as the event could be multifactorial in nature including patient and/or procedure related factors.Secondary surgical intervention to remove/replace/reposition the lens is identified in the labeling as a known potential adverse event following icl implantation.Claim #(b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted an implantable collamer lens into a left eye (os) on (b)(6)2023.The patient underwent bilateral sequential surgery with os as the second eye.Concomitant products used intraoperatively include the msi delivery system, ovd (opegan) and coaxial i/a handpiece use for 30 sec for its removal.Tass was diagnosed on day 7 and reported as mild inflammation with ac cell++ and conjunctival hyperemia resulting in patient experience of blurred vision.Treatment included topical steroids/antibiotic drops and steroid injection.By (b)(6) 2024 the issue resolved and bcva returned to pre-operative 20/13 with iop 12mmhg.The lens remains implanted.The reporter does not state a cause for the event.
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).
Additional Manufacturer Narrative
Additional information: appeared on day 7=> improved on day 14 there was inflammation but it was mild" and corrected visual acuity remained as 20/13 throughout the follow up period.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 91016
• Manufacturer Contact: joselene muniz ; 800 royal oaks dr. suite:210; monrovia, CA 91016
• MDR Report Key: 20843900
• Report Number: 2023826-2024-05248
• Device Sequence Number: 11701739
• Product Code: MTA
• UDI-Device Identifier: 00840311300198
• UDI-Public: (01)00840311300198(11)230621(17)260531
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/08/2024

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
• Device Expiration Date: 05/31/2026
• Device Model Number: VICM5_12.1
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/08/2024
• Supplement Date Received by Manufacturer: 12/02/2024; 03/23/2026
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 02/05/2025; 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2023
• 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-UNK, LOT# UNK.; INJECTOR MODEL-UNK,LOT-#-UNK.; UNK MODEL-FTP, LOT# UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 26 YR
• Patient Sex: Male