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

Model Number	VICM512.1
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	04/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A4-a6: unk.H6: work order search: no similar complaints within associated lots were found.Manufacturer narrative: a review of the device labeling was completed.Iritis (iridocyclitis), anterior chamber cells and fibrin precipitation 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.(b)(6) were used during the procedure and is a viscous cohesive of purified sodium hyaluronate manufactured by seikagaku.(11) when folding and inserting this product, use the following insertion device.Microstaar injector, microstaar foam tip plunger, icl cartridge.To avoid damaging the product, use forceps with rounded edges and no serrations on the surface.Toxic anterior segment syndrome (tass) is an acute sterile postoperative inflammation that can occur after uncomplicated or complicated intraocular surgery.The handpiece (which is a reusable instrument) was used.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.It should be noted multiple cases of similar clinical presentation were reported from the same facility under the same surgeon.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 an implantable collamer lens into a right eye (od) on (b)(6)2024.The patient underwent bilateral sequential surgery.Concomitant products used intraoperatively include the msi-pf injector, sfc-45 cartridge with foam tip plunger, ovd (b)(6) and coaxial i/a handpiece for its removal for 60 sec.Tass was diagnosed on day 1.Inflammation was reported as moderate presenting with ac cell+++, ciliary hyperemia and mild fibrin over the pupil resulting in patient experience of blurred vision.Treatment included: ac lavage, topical, oral and subconjunctival injection of steroids.The issue was resolved on day 2 and the lens remains implanted.Per information on (b)(6)2024, ocular status was reported as ucva 20/13 and iop 11mmhg.The reporter does not state a cause for the event.
Additional Manufacturer Narrative
H6: device history record review indicates that the product has been manufactured within the established process parameters and that there is no indication that the manufacturing and/or 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 SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 800 royal oaks dr. suite 210; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 20843322
• Report Number: 2023826-2024-05319
• Device Sequence Number: 3838555
• Product Code: MTA
• UDI-Device Identifier: 00840311300181
• UDI-Public: (01)00840311300181(11)231104(17)261031
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 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
• Operator of Device: Health Professional
• Device Model Number: VICM512.1
• 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: 11/08/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/04/2023
• 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# 1660113.; FOAM TIP PLUNGER - LOT# UNK.; INJECTOR MODEL: MSI-PF - LOT# UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male