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

Model Number	VICM5 13.2
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); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: investigation type code: 4110- lens work order search-no similar complaint event(s) within associated lots were found.H6: type of investigation code: 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.H11: manufacturer narrative: a of the device labeling was completed.Iritis (iridocyclitis), uveitis are identified in the labeling as known potential 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.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
A facility representative reported that a 13.2 mm vicm5 -5 d implantable collamer lens (icl) was implanted into the patient's right eye (od) on (b)(6) 2024.The patient underwent bilateral sequential surgery.Concomitant products used intraoperatively include opegan ovd and the msi injector delivery system.Toxic anterior segment syndrome (tass) was diagnosed.Additional diagnostics were performed but cultures were not taken.Eye drops and oral medication were prescribed.As of on (b)(6) 2024, issues were reported to be resolved with patient condition: bcva/ucva:20/10; iop:15mmhg; vault:509 m; "pigmentation has improved considerably".The lens remains implanted.In the reporter opinion, the cause of the event was reported as unknown.
Additional Manufacturer Narrative
Additional data: h6.- health effect- clinical code: 4581- 'conjunctival hyperemia' and '2137' should be added.B5.- the patient also experienced blurred vision and conjunctival hyperemia.It was later reported, 'corrected visual acuity remained good at 20/10 even during inflammation onset, but blurred vision and redness present'.The lens remains implanted.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 CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 20700783
• Report Number: 2023826-2024-04900
• Device Sequence Number: 3783315
• Product Code: MTA
• UDI-Device Identifier: 00840311300839
• UDI-Public: (01)00840311300839(11)231102(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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2024

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: VICM5 13.2
• 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: 10/22/2024
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 03/11/2026
• Date Device Manufactured: 11/02/2023
• 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.; MSI-PF, LOT# UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 YR
• Patient Sex: Male