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 Codes	Toxic Anterior Segment Syndrome (TASS) (4469); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation type 4110: lens work order search- three similar complaint event(s) within associated lots were found.A review of the device labeling was completed.Inflammation, iritis and corneal opacity are identified in the labeling as a known potential adverse event 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.Under other defects there is a possibility of (3) foreign matter adhering to the lens surface.In that case, it is necessary to stop inserting the lens, or to remove and reinsert the lens.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.Claim#: (b)(4).
Event or Problem Description
The reporter indicated that a 12.6mm vicm5 -3.50d implantable collamer lens was implanted into the patient's right eye (od) on (b)(6) 2024.Concomitant products used intraoperatively include opegan viscoelastic and the msi injector system.Toxic anterior segment syndrome (tass) was diagnosed.No additional diagnostics were performed.Antibiotic and steroid ophthalmic drops were prescribed.Diffuse deposits on the posterior cornea and inflammatory opacity on the lens surface have improved "but still slightly cloudy".Per last visit conducted on (b)(6) 2024, visual acuity was reported to be good, the bcva was 20/13 equivalent to pre-op.Per same visit iop was 13 mmhg and vault was 1.4 ct.The lens remains implanted.
Additional Manufacturer Narrative
Additional information: 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.Claim# (b)(4).
Additional Manufacturer Narrative
Additional information: b5- corneal erosion was also experienced.It was reported that inflammatory recovery was observed 130 days post-operatively.H6- clinical code 4581- corneal erosion.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: 19312318
• Report Number: 2023826-2024-02125
• Device Sequence Number: 7010493
• Product Code: MTA
• UDI-Device Identifier: 00840311300471
• UDI-Public: 00840311300471
• 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): 04/17/2024

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2024
• Supplement Date Received by Manufacturer: 09/16/2024; 08/21/2025
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 09/20/2024; 10/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2023
• 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 Sex: Unknown