MAUDE Adverse Event Report: STAAR SURGICAL 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 Codes	Blurred Vision (2137); Toxic Anterior Segment Syndrome (TASS) (4469)
Date of Event	06/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that the surgeon implanted an implantable collamer lens into a right eye (od) on (b)(6) 2024.Concomitant products used intraoperatively include: msi-pf injector, sfc-45 cartridge with foam tip plunger, ovd (opegan, opegan hi) and a coaxial i/a handpiece for its removal for 60 sec.Tass was diagnosed on day 1 described as mild inflammation with cell++, conjunctival hyperemia, moderate deposition (unspecified) on the lens surface and patient experience of blurred vision.Treatment included: ac lavage, topical, oral and subconjunctival injection of steroids.On day 2 recovery was observed.Based on last follow up on (b)(6) 2024, the issue resolved with bcva 20/10 (better than pre-op) and iop 16mmhg.The lens remains implanted.The reporter does not state a cause for the event.
Additional Manufacturer Narrative
H6 - type of investigation: 4110 - lens work order search: no similar complaint type events reported for units within the same lot.H6 - type of investigation 3331 - the device history record (dhr) review indicated that the product had been manufactured within the established process parameters and that there was no indication that the manufacturing and/or processing of the device contributed to the complaint issue.Manufacturer narrative: 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 and opegan hi 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).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 20849587
• Report Number: 2023826-2024-05460
• Device Sequence Number: 8100424
• Product Code: MTA
• UDI-Device Identifier: 00840311300549
• UDI-Public: (01)00840311300549(11)231119(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): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• 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 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: 11/08/2024
• Initial Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/19/2023
• 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 W/FTP, LOT# 1664126; INJECTOR MODEL: MSI-PF, LOT# UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 24 YR
• Patient Sex: Male