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

Model Number	VTICMO12.6
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	03/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that a 12.6mm vticmo12.6 implantable collamer lens of a -16.0/2.0/095 was implanted by the surgeon into the patient's right eye (od).Concomitant product information used intraoperatively including viscoelastic and delivery system type were not provided.Per the reporter, "one year after the initial surgery and day 1 after surgery to increase spherical power", toxic anterior segment syndrome (tass) was diagnosed.Pupil fibrin was observed.Diagnostic cultures were not performed but antibiotic and steroid ophthalmic drops as well as oral steroids were prescribed.Visual acuity was noted as of (b)(6) 20224 to be improved from 1.0 (~20/20) to 1.2 (~20/15).The lens remains implanted.
Additional Manufacturer Narrative
A4-a6:unk.H6: work order search: no similar complaints within associated lots were found.Manufacturer's narrative: a review of the device labeling was completed.The directions for use states a contraindication for implantation in eyes (7) suspicion of iritis, or past history.Iritis is identified in the labeling as a known potential adverse event following icl implantation.The reporter states the initial lens implanted one year earlier was replaced for a different lens power and tass was diagnosed day 1 upon implantation of the replacement lens.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.To date the icl remains implanted.Claim# (b)(4).
Additional Manufacturer Narrative
Additional information - d6a: 25-feb-2024.Claim# (b)(4).
Additional Manufacturer Narrative
Device history record: dhr 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.Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC TORIC 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: 19102335
• Report Number: 2023826-2024-01287
• Device Sequence Number: 15310424
• Product Code: QCB
• UDI-Device Identifier: 00840311323142
• UDI-Public: 00840311323142
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P030017
• 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): 03/15/2024

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: VTICMO12.6
• 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: 03/15/2024
• Supplement Date Received by Manufacturer: 06/19/2024; 06/27/2024
• Initial Report FDA Received Date: 04/12/2024
• Supplement Report FDA Received Date: 06/19/2024; 06/28/2024
• 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: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown